Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): A study protocol for a randomized controlled trial

doi:10.21203/rs.2.12203/v2

Download PDF

Study protocol

Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): A study protocol for a randomized controlled trial

https://doi.org/10.21203/rs.2.12203/v2

This work is licensed under a CC BY 4.0 License

Journal Publication

published 08 Jan, 2020

Read the published version in Trials →

You are reading this older preprint version

Read the latest preprint version →

Background Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anesthesia. It limits patients’ general activity and increases hospital length of stay and use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment of PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence suggests the effectiveness of adrenocorticotropic hormone (ACTH) in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, in the treatment of PDPH in patients who received neuraxial anesthesia during labor. Method This is a randomized, double-blinded, placebo-controlled, parallel-arm trial, performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomized to receive either 1 mg of tetracosactide intravenously over 20 min, or 0.9% saline (placebo). The primary endpoint of the study is the rate of epidural blood patch within a 15-day follow-up period. Duration of headache, intensity of pain, reduction of general activity, increase of hospital length of stay, adverse events, analgesic use (type and duration), and number of blood patches per patient in each group are recorded. Discussion We expect a decrease in the use of epidural blood patch in those who receive tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a noninvasive alternative to blood patch in the treatment of PDPH.

Internal Medicine

Integrative & Complementary Medicine

Translational Medicine

Post dural puncture headache

tetracosactide

cosyntropin

postpartum

blood-patch

epidural

Epidural analgesia is the most effective method used to control pain during labor and is frequently used in France (77% of vaginal deliveries in 2010) (1). Spinal anesthesia is preferred for cesarean section, artificial delivery, or uterine revision because of the risk associated with general anesthesia in pregnant women (such as difficult of airway management (2)). However, neuraxial anesthesia can also lead to adverse effects, in particular post-dural puncture headache (PDPH). The incidence of PDPH among those with dural puncture mainly depends on the type of needle (diameter, bevel) (3–10); for instance it is reported to be between 0.7% and 4% for 24-27 G conical needles used for spinal anesthesia, and 50-85% for large Tuohy needles used for epidural analgesia (3,10,11). However, the incidence of PDPH among patients receiving these types of anesthesia is close, as the incidence of dural puncture during epidural placement is reported to range from 0.04 to 6% (12). In addition, postpartum women are more prone to PDPH than the general population (13–15).

PDPH is a clinical diagnosis. According to the International Headache Society, it is a severe postural, bilateral, disabling, constrictive, occipital or diffuse headache, radiating to the neck that develops within 7 days after the dural puncture. In 66% of cases it occurs during the first 48 hours, and in 90% during the first 3 days (3). PDPH is aggravated by a sitting or standing position and is relieved by lying down. Other symptoms such as neck stiffness, hearing disorders (tinnitus, hypoacusia) (16), dizziness, photophobia, nausea or vomiting, and diplopia by injury of the cranial nerve IV (17) may be associated with the headache and patients remain afebrile. Differential diagnoses are migraine, pre-eclampsia, meningitis, intracranial hemorrhage, cerebral thrombosis, pneumocephalus, and tension headaches (18,19).

Intracranial hypotension by leakage of cerebrospinal fluid (CSF) appears as the main cause of PDPH, as described by Vandam and Dripps as early as 1956 (20). CSF is critical to reduce impacts between the brain and the cranium during orthostatism and the loss of this cushioning leads to headaches. Furthermore, the cerebral and meningeal vessels are stressed during the downward displacement of the brain in orthostatism. This caudal traction activates the stretch-sensitive receptors of the trigeminal nerves (frontal headache), glosso-pharyngeal and vagus nerves (occipital headache) (11,21,22), and the first three cervical nerves (arm pain or neck pain) (23). According to the Monro-Kellie theory, headaches may also be related to painful venous and arterial cerebral vasodilation which compensates for decreased CSF volume (3,21). In the inner ear, hypotension of the perilymph also causes an imbalance between endolymph and perilymph itself leading to an impairment of hearing, tinnitus and/or vertigo (16,24).

In most cases, dural puncture closes spontaneously without consequence. PDPH is reported to resolve in more than 50% of patients within 4 days, and in more than 70% within a week (although headache may persist in a limited number of patients) (3,20). However, PDPH limits patients’ activity, increases the duration of hospital stay and the use of care (25), and it is particularly disabling during the postpartum period, when the mother has to take care of her child. It is therefore important to treat this syndrome. Epidural blood patch is currently the gold-standard and most effective treatment for PDPH. However, the moment at which the blood patch must be performed remains uncertain. On the one hand, some studies have suggested a greater risk of failure with early blood patch although no causal link could be established (26–28), however it has been suggested that the severity of CSF leak could explain the diminished effectiveness of early blood-patch (28). On the other hand, a delayed blood patch could increase the duration of bed rest while waiting for this intervention. A delay of 24 to 36 hours between the onset of headaches and the completion of a blood patch seems reasonable and it is recommended not to delay it by more than 48 hours (29).

Historically the reported rate of success after the first blood patch is around 80% (28,30), yet more recently efficacy has been found to be lower (at most 32%) (27). However, it is an invasive procedure that may result in rare but serious complications such as spinal subdural hematoma (31) or permanent paraparesis and cauda equina syndrome (32), but also it may trigger anxiety and discomfort in patients and can sometimes be painful (back pain, transient bradycardia).

Alternative treatments have been studied recently; these aim to be less invasive or to reduce headache intensity whilst waiting for the blood patch or the disappearance of PDPH. Several lines of evidence have suggested the effectiveness of adrenocorticotropic hormone (ACTH) in the management of PDPH (33–41). Several mechanisms have been proposed to explain the effects of ACTH or its analogues on headaches. First, it has been shown by several teams that fragments of ACTH interact with opioid receptors in vitro and have morphine-like effects in vivo (42–44). Second, ACTH may increase brain β-endorphins that change the perception of pain (35–37). Third, ACTH stimulates the adrenal cortex which releases different hormones such as glucocorticoids, androgens, and mineralocorticoids. Glucocorticoids have an anti-inflammatory effect that may explain in part the analgesia observed after ACTH injection (38). Fourth, mineralocorticoids are responsible for fluid retention that may lead to meningeal edema and overlapping edges of the dural puncture (36).

The trial reported by Hakim found that administration of tetracosactide after accidental dural puncture in 90 parturients was associated with a significant reduction in the incidence of PDPH and requirement for epidural blood patch (39). The efficacy of tetracosactide for the treatment of PDPH in 32 patients has been reported to be 56% (95% CI [33; 79%]) (40), and to be similar to that of epidural blood patch in a study that included 28 patients (41) although 4 of the 15 in the tetracosactide group also received a blood patch. However, a randomized trial that included 18 patients did not find any efficacy of tetracosactide to treat PDPH, nor to reduce the use of blood patch (45). This study was conducted among a small group of patients, and did not report any data on the interval between PDPH onset and blood patch. Taken together, evidence for the efficacy of ACTH analogues on PDPH remains limited with contradictory results obtained in small groups of patients. It is therefore difficult to conclude and establish a protocol for the management of PDPH.

In the proposed study, we have designed a therapeutic trial to evaluate the efficacy of tetracosactide in the treatment of PDPH in 88 postpartum patients.

1.3.1 Aim of the study

The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen^®) in the treatment of post-dural puncture syndrome for patients who received neuraxial anesthesia during childbirth.

Our working hypothesis is that a single intravenous infusion of tetracosactide may avoid the need for epidural blood patch. To challenge this hypothesis we compare two groups: the study group receives an infusion of 1 mg of tetracosactide whereas the control group receives a placebo (0.9% saline). Both groups receive standard analgesic treatment and epidural blood patch if needed (after a minimum 24 h following the injection of the experimental treatment).

1.3.2 Trial Design

The study is a randomized, double-blind, placebo-controlled, parallel-arm, double centers trial. It is conducted in two sites of a French university hospital. Patient enrollment started in October of 2016 and was expected to be completed within 2 years after the start of the study. However, this did not happen as explained below.

Once participants are enrolled in the study with informed consent, they are randomized into the two study arms. The study group receives 1 mg of tetracosactide intravenously whereas the control group receives 0.9% saline. Outcomes will be measured between 2 and 6 hours, at 1 day, 2 days, 3 days, and between day 13 and 17 post-randomization. Adverse events are collected throughout the study.

1.3.3 Primary endpoint

The primary endpoint of the study is the rate of epidural blood patch within a 15-day follow-up period. That is, the number of patients who get a blood patch within the 15 days period over all participants included.

1.3.4 Secondary endpoints

The secondary endpoints are:

duration of headache: mean number of days with headache within the 15-days follow-up period
intensity of headache (11-point numerical rating scale, NRS) (46): mean NRS at day 1, 2, 3, and 15
the need for analgesic treatments (descriptive analysis of type, interval after study treatment, and duration) within the 15-day follow-up period
appearance of associated features (neck stiffness, tinnitus, hypoacusia, photophobia, diplopia, dizziness or nausea): descriptive analysis of these features within the 15-day follow-up period
activity limitation (qualitatively, as described in Figure 1, and quantitatively on a scale from 0 to 100%; both self-assessed)
hospital length of stay: mean number of days spent in hospital from the inclusion to the 15^th day of follow-up
the number of epidural blood patches performed per patient: mean number within the 15-day follow-up period
tolerance, assessed by the collection of all adverse events (type, frequency, severity)

1.3.5 Population

Number of patients needed

The sample size calculation is based on a previous study that investigated tetracosactide in PDPH (39) and, retrospectively, on observational data from our hospital database. The primary endpoint is the rate of blood patch in the two groups. We defined the efficacy of tetracosactide as a decrease in blood patch use by 30% in the tetracosactide group, a clinically relevant difference reducing the need for invasive treatment and replacing it with an easily administered treatment that has a known safety profile.

In our center, 90% of patients with PDPH after epidural analgesia receive a blood patch. The study reported by Hakim (39) found a greater than 50% decrease in PDPH incidence and blood patch use after prophylactic treatment with tetracosactide, in a context of epidural analgesia. We therefore need to include 44 subjects in each group, given power of 0.80 and type I error of 0.025 (α=2.5% Fisher’s exact test, power of 80%, p1=0.9; p2=0.6), to reduce blood patch requirement by 30%. Thus a total of 88 patients need to be randomized.

Eligibility

Patients eligible for enrolment in this clinical trial are those suffering from PDPH due to epidural analgesia, combined spinal-epidural analgesia, or spinal anesthesia for childbirth.

The characteristics of headache should be as follows:

within five days after delivery
relieved in the supine position and/or worse while sitting or standing
intense (NRS >3/10)
with or without neck stiffness, tinnitus, hypoacusia, photophobia, visual impairment, nausea or vomiting
having eliminated differential diagnosis: pre-eclampsia or eclampsia, cerebral venous thrombosis, migraine.

Patients must be at least 18 years old and benefit from healthcare insurance. They also have to provide a written informed consent.

Exclusion criteria

Exclusion criteria are as follows:

diplopia (which requires an epidural blood patch without delay)
contraindication to ACTH: uncontrolled arterial hypertension, uncontrolled diabetes mellitus, acute psychosis, infectious diseases
contraindication to tetracosactide:
- currently receiving a drug associated with an increased risk of Torsades de Pointes: astemizole, bepridil, IV erythromycin, halofantrine, pentamidine, sparfloxacine, sultopride, terfenadine, vincamine
- patient who received a live vaccine in the month prior to inclusion
previous history of hypersensitivity to tetracosactide
patient who has previously received tetracosactide since childbirth
contraindication to epidural blood patch: HIV, HVC, leukocytosis, fever
pre-eclampsia or eclampsia during this pregnancy (may be confounding for the etiology of headache)
patient who has already received a prophylactic blood patch (at the time of accidental dural puncture diagnosis)
Under 18 years old or adult under guardianship
Mental disorder which does not allow informed consent
Patients who are enrolled in another clinical trial

Consent

When PDPH diagnosis is made by the anesthesiologist, screening of patients for inclusion and exclusion criteria is performed. The investigator then presents the study to the patients. Written information is provided to the patients. Final inclusion occurs after a few minutes during which they read the information letter, and after they had asked any questions that they may have, but also after signing written informed consent.

1.3.6 Randomization, blinding, and data management

The anesthesiologist checks patient inclusion criteria and the absence of exclusion criteria. After signing informed consent, patients are randomized online using the ClinSight-Online software program (Ennov society, Paris, France). The randomization list was compiled by a statistician, entered into the software and communicated to the pharmacist (who prepares the numbered treatment kit). The randomization is performed by block stratification according to site. Patients are allocated to a treatment number (by the ClinSight software). The study is performed as a double-blinded study; both patients and the medical team are blinded to treatment allocation. An anesthetic nurse prepares the treatment according to the assigned number to which the rest of the healthcare team is blinded. Patient data are collected on electronic case report forms (eCRFs). The sponsor will independently monitor both locations of this multisite trial every ten patients. This data monitoring is performed by a clinical research associate (CRA). His/her role is to check the consent form, the quality of data collection (missing data, data entry errors…), the availability of treatment at each site, the pharmacy process, and the declaration of any serious advert event. He/she is employed by the sponsor but is independent of the investigators and is not involved in carrying out the study or interpretation of the results. Anonymized data are only accessible to investigators, sponsor, and authorized persons (statistician, data manager…). They will be stored confidentially for 15 years by the sponsor. They will not be used for further studies without further patient agreement. At the end of the study, we plan to communicate trial results to participants, healthcare professionals, and the public via a peer-reviewed publication. Author will be considered by substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work. They must have draft the work or revisit it critically. They will all approve the final version to be published. We do not expect the participation of a professional writer. Data not disclosed in the publication will not be accessible.

1.3.7 Intervention protocols

During the post-partum period, patients are usually followed by midwives. In case of headache, whether an accidental dural puncture was diagnosed or not, the anesthesiologist is warned by midwives. Therefore any symptomatic patient is examined by an anesthesiologist. The study investigators are the anesthesiologists working in the maternity department in the two centers.

Patients are enrolled when diagnosed with PDPH based on the clinical evaluation of the anesthesiologist. They are randomized to receive intravenous tetracosactide or placebo. In the study group, patients receive a single intravenous injection of 1 mg tetracosactide (Synacthen^®, Sigma-Tau laboratory, Roma, Italy). Four vials containing 0.25mg tetracosactide (in 1 ml of solvent) are reconstituted in 100 ml of normal saline (0.9% NaCl). This solution is infused intravenously over 20 min. In the control group, patients receive an equal volume of normal saline: 104 ml over 20 min. The whole intervention is administered over a 20 minutes course and therefore is not modifiable once begun except for the occurrence of a side effect. A side effect is here defined by any new abnormality of the clinical examination occurring during the injection. In this case, the treatment is immediately stopped but monitoring and data collection is continued.

Standard analgesic medication is also initiated in both groups from the beginning of headache as concomitant treatments, as follows:

for mild headache (NRS<3/10): 1 g paracetamol and 400 mg ibuprofen orally every 6 hours
for moderate headache (NRS=3): nefopam 20 mg and/or a combination of paracetamol 300 mg and opium 10 mg is given in addition every 4 hours
for severe headache (NRS≥4): morphine 10 mg orally every 4 hours can be added as required

These treatments are adjusted daily.

The primary and secondary endpoint, including tolerance criteria, are evaluated blinded during infusion of study treatment, 2-6 hours later, 1 day, 2 days, 3 days, and between 13 and 17 days post-treatment by the investigator. The latter is conducted by phone call in order to increase the complete follow-up. The total duration of the study is therefore 13 to 17 days. Any alternative analgesic interventions required after receiving the study treatment are reported at each time point as indicated above. The study timeline is summarized in Figure 2.

Epidural blood patch is performed for patients who reported a persistent moderate to severe headache a minimum of 24 hours after administration of the study treatment and 36 hours after the dural puncture based on the clinical appreciation of the anesthesiologist. Epidural blood patch can be repeated twice if required (i.e. if headache does not improve or if it increases again). Epidural blood patch is performed by the anesthesiologist. Autologous blood is injected into the epidural space using an 18 gauge Tuohy needle. The injection is stopped when the patient feels pressure in the lower back or pain.

1.3.8 Statistical analysis

Unblinding occurs at the end of the study and once the database has been frozen. Analyses will be carried out on an intention-to-treat (ITT) basis. If data is missing from visits, we will carry forward the last value. This considers that the pain (and others symptoms) has not improved, which is the most pessimistic scenario in this condition (which we know is improving spontaneously). Blood patch can only be performed at the hospital, and it is therefore very unlikely that there will be missing data regarding for the primary endpoint. If a patient does not receive full treatment, she will be included in the group to which she was randomized for the ITT analysis. Statistical analyses will be performed using IBM SPSS statistics for windows (IBM corp., Armonk, NY, USA) and R (R Foundation for Statistical Computing, Vienna, Austria). All data will be checked for normal distribution using the Kolmogorov test. For normally distributed data, variables will be presented as mean ± standard deviation (SD). Non-normally distributed data will be presented as the median and interquartile range [IQR]. Categorical variables will be presented as number and percentage of the total. To compare the two groups (tetracosactide and placebo), we will use Fisher’s exact test for qualitative data and the non-parametric Mann-Whitney tests for quantitative variables. A comparison of the two groups at randomization will identify potential bias due to unequal allocation. A multivariate logistic regression analysis will be performed to study factors independently associated with the response to tetracosactide and to control potential confounding factors.

Intermediate analysis

The hypothesis of a 30% difference between the two groups is conservative compared to the 50% reduction reported by Hakim (39); a difference of only 30% between the two groups should already be clinically relevant. An interim analysis is therefore planned after enrollment of 44 patients. The overall alpha risk will be adjusted according to the Bonferroni method and will be 2.5% (5% / 2). A p value <0.025 will therefore be considered statistically significant. If this initial analysis is statistically significant (p <0.025), the independent monitoring committee may decide to stop the study without waiting for the planned recruitment. Otherwise, the study will be continued until the inclusion of 88 patients.

1.3.9 Ethical approval

This trial is conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). It is also conducted in accordance with French legislation (Public Health Code; Act No. 2004-806 of August 9, 2004). It is registered in Clinical Trial Protocol Registration and Results System: NCT02813655 (registration date: June 24, 2016). An ethics committee (comité de protection des personnes sud Est V, CPP) has approved the study for both participating sites on April 6, 2016. The national drugs authority (Agence Nationale de Sécurité du Médicament et des produits de santé, ANSM) authorized this trial (authorization date: April 18, 2016).

1.3.10. Adverse events management

During the study period, adverse events will be reported and recorded in the participants’ CRF. The severity of adverse events will be graded as mild, moderate, severe, life threatening or death, and the potential relationship between the adverse event and the study treatment will be assessed by clinical judgment. If an adverse event requiring extension of hospitalization or causing a medically critical situation occurs, the event will be recorded as a severe adverse event. All severe and life threatening adverse events or death will be reported to the investigator and to the sponsor within 24 hours after the information has been collected. The sponsor will report all such events to legal authority (ANSM and CPP). The investigator must follow patients until the adverse event has been resolved. A severe adverse event is the only reason for unblinding participants and providers before the end of the study. It will be performed by the Centre anti-poison (poison control center) which is independent of the study and is the only party with access to the randomization list.

1.3.11. Protocol amendment

Because patient enrollment/inclusion was more difficult than expected the protocol was amended (January 2017) to extended inclusion from PDPH due to a dural puncture carried out by large Tuohy needle to all postpartum PDPH, i.e. PDPH related to a large dural puncture and PDPH related to small needle (25-27G) for spinal anesthesia. A second amendment (November 2018) extended the inclusion period until October 10, 2021 to allow the further progress of the study.

We propose herein a protocol to investigate the use of tetracosactide, an ACTH analogue, to treat PDPH. Blood-patch is currently the gold standard for PDPH treatment, and tetracosactide could be interesting by reducing the need for the invasive procedure and replacing it with an easily administered treatment that has a known safety profile. Given the result were obtained in small groups of patients, the efficacy of ACTH analogues for PDPH remains limited.

Initially, the inclusion was limited to PDPH due to a dural puncture carried out by large Tuohy needle. Because patient enrollment/inclusion was more difficult than expected the protocol was amended to extended inclusion to all postpartum PDPH. This widening of the inclusion criteria raises the issue of population heterogeneity, which we hope to limit by the randomization process.

Since the management strategy of PDPH (with blood-patch and non-invasive treatments) is not clearly defined, the rate of blood-patch varies. Rucklidge, for example, described that 50 blood-patches were received by 144 patients treated for PDPH after epidural anesthesia over 20 years in the hospital in which he practiced (47); the blood-patch rate was therefore 35%. In the study reported by Aya et al. all patients (100%) treated for PDPH after epidural obstetric anesthesia in their unit received a blood-patch (48). Therefore, a potential limitation of the study described herein is that the sample size could be insufficient if the rate of blood patch in the control group is lower than 90%.

Trial status

It is the fourth protocol version dated September 28, 2018. The study is ongoing; the first patient was included in October 2016, and in May 2019 a total of 25 patients had been enrolled. Initially we expected to finalize the study in October 2018, but we had to extend the inclusion phase until 2021 to reach a total of 88 inclusions. Due to the ongoing nature of the study and in order to avoid influencing its conduct, the final results are not presented herein. An intermediate analysis will be performed after 44 inclusions, and if there significant difference in the primary outcome is found the study will be discontinued.

We expect a decrease in the use of epidural blood patch in those who receive tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a non-invasive alternative to blood patch in the treatment of PDPH.

ACTH Adrenocorticotropic Hormone

ANSM Agence Nationale de Sécurité du Médicament et des produits de santé : the national drugs authority

CPP Comité de Protection des Personnes : an ethics committee

CRA Clinical Research Associate

CSF Cerebrospinal Fluid

eCRFs electronic Case Report Forms

GCP Good Clinical Practice

HIV Human Immunodeficiency Virus

HCV Hepatitis C Virus

IQR Interquartile Range

ITT intention-to-treat

NRS Numerical Rating Scale

PDPH Post-Dural Puncture Headache

SD Standard Deviation

Ethics approval and consent to participate

An ethics committee (comité de protection des personnes sud Est V, CPP) has approved the study for both participating sites on 6 April 2016. Patients were included after a few minutes during which they read the information letter, and after they had asked any questions that they may have, but also after signing written informed consent.

Consent for publication

Not applicable

Availability of data and materials

Data sharing is not applicable to this article as no datasets were yet generated or analyzed during the current study.

Competing interests

The authors have no conflict of interest to declare.

Funding

The study is funded by grants from Fondation Apicil and Fondation de France.

Funders have no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.

Authors’ contributions

Célia Depaulis was a major contributor in writing the manuscript. Nadia Steer, Dominique Chassard and Frederic Aubrun read and approved the final manuscript. No professional writer contributed.

Kpéa L, Bonnet M-P, Le Ray C, Prunet C, Ducloy-Bouthors A-S, Blondel B. Initial Preference for Labor Without Neuraxial Analgesia and Actual Use: Results from a National Survey in France. Anesth Analg. 2015 Sep;121(3):759–66.
Yıldırım İ, İnal MT, Memiş D, Turan FN. Determining the Efficiency of Different Preoperative Difficult Intubation Tests on Patients Undergoing Caesarean Section. Balkan Med J. 2017 Sep 29;34(5):436–43.
Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718–29.
Matas SL de A. Why should we use atraumatic needles in lumbar puncture? Arquivos de Neuro-Psiquiatria. 2013 Sep;71(9B):681–4.
Evans RW, Armon C, Frohman EM, Goodin DS. Assessment: prevention of post-lumbar puncture headaches: report of the therapeutics and technology assessment subcommittee of the american academy of neurology. Neurology. 2000 Oct 10;55(7):909–14.
Flaatten H, Felthaus J, Kuwelker M, Wisborg T. Postural post-dural puncture headache. A prospective randomised study and a meta-analysis comparing two different 0.40 mm O.D. (27 g) spinal needles. Acta Anaesthesiol Scand. 2000 Jul;44(6):643–7.
Lambert DH, Hurley RJ, Hertwig L, Datta S. Role of needle gauge and tip configuration in the production of lumbar puncture headache. Reg Anesth. 1997 Feb;22(1):66–72.
Lavi R, Yarnitsky D, Yernitzky D, Rowe JM, Weissman A, Segal D, et al. Standard vs atraumatic Whitacre needle for diagnostic lumbar puncture: a randomized trial. Neurology. 2006 Oct 24;67(8):1492–4.
Halpern S, Preston R. Postdural puncture headache and spinal needle design. Metaanalyses. Anesthesiology. 1994 Dec;81(6):1376–83.
Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460–9.
Diemunsch P, Schlotterbeck H, Pottecher J. Brèches dure-méro-arachnoïdiennes. Conférence d’actualisation 2003 [Internet]. SFAR. 2003; Available from: http://www.sfar.org/acta/dossier/archives/ca03/html/ca03_09/ca03_09.htm
Basurto Ona X, Uriona Tuma SM, Martínez García L, Solà I, Bonfill Cosp X. Drug therapy for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2013;2:CD001792.
Wu CL, Rowlingson AJ, Cohen SR, Michaels RK, Courpas GE, Joe EM, et al. Gender and post-dural puncture headache. Anesthesiology. 2006 Sep;105(3):613–8.
Diaz JH. Epidemiology and outcome of postural headache management in spontaneous intracranial hypotension. Reg Anesth Pain Med. 2001 Dec;26(6):582–7.
Bezov D, Lipton RB, Ashina S. Post-Dural Puncture Headache: Part I Diagnosis, Epidemiology, Etiology, and Pathophysiology. Headache: The Journal of Head and Face Pain. 2010 Jun 1;50(7):1144–52.
Pogodzinski MS, Shallop JK, Sprung J, Weingarten TN, Wong GY, McDonald TJ. Hearing loss and cerebrospinal fluid pressure: case report and review of the literature. Ear Nose Throat J. 2008 Mar;87(3):144–7.
Nishio I, Williams BA, Williams JP. Diplopia: a complication of dural puncture. Anesthesiology. 2004 Jan;100(1):158–64.
Goldszmidt E, Kern R, Chaput A, Macarthur A. The incidence and etiology of postpartum headaches: a prospective cohort study. Can J Anaesth. 2005 Nov;52(9):971–7.
Bleeker CP. Postpartum post-dural puncture headache: is your differential diagnosis complete? British Journal of Anaesthesia. 2004 Sep 1;93(3):461–4.
Vandam LD, Dripps RD. Long-term follow-up of patients who received 10,098 spinal anesthetics; syndrome of decreased intracranial pressure (headache and ocular and auditory difficulties). J Am Med Assoc. 1956 Jun 16;161(7):586–91.
Fournet-Fayard A, Malinovsky J-M. [Post-dural puncture headache and blood-patch: theoretical and practical approach]. Ann Fr Anesth Reanim. 2013 May;32(5):325–38.
Candido KD, Stevens RA. Post-dural puncture headache: pathophysiology, prevention and treatment. Best Pract Res Clin Anaesthesiol. 2003 Sep;17(3):451–69.
Schabel JE, Wang ED, Glass PS. Arm pain as an unusual presentation of postdural puncture intracranial hypotension. Anesth Analg. 2000 Oct;91(4):910–912, table of contents.
Lybecker H, Andersen T, Helbo-Hansen HS. The effect of epidural blood patch on hearing loss in patients with severe postdural puncture headache. J Clin Anesth. 1995 Sep;7(6):457–64.
Angle P, Tang SLT, Thompson D, Szalai JP. Expectant management of postdural puncture headache increases hospital length of stay and emergency room visits. Can J Anaesth. 2005 Apr;52(4):397–402.
Loeser EA, Hill GE, Bennett GM, Sederberg JH. Time vs. success rate for epidural blood patch. Anesthesiology. 1978 Aug;49(2):147–8.
Paech MJ, Doherty DA, Christmas T, Wong CA, Epidural Blood Patch Trial Group. The volume of blood for epidural blood patch in obstetrics: a randomized, blinded clinical trial. Anesth Analg. 2011 Jul;113(1):126–33.
Safa-Tisseront V, Thormann F, Malassiné P, Henry M, Riou B, Coriat P, et al. Effectiveness of epidural blood patch in the management of post-dural puncture headache. Anesthesiology. 2001 Aug;95(2):334–9.
Les blocs périmédullaires chez l’adulte. Annales Françaises d’Anesthésie et de Réanimation. 2007 Jul;26(7–8):720–52.
van Kooten F, Oedit R, Bakker SLM, Dippel DWJ. Epidural blood patch in post dural puncture headache: a randomised, observer-blind, controlled clinical trial. J Neurol Neurosurg Psychiatr. 2008 May;79(5):553–8.
Verduzco LA, Atlas SW, Riley ET. Subdural hematoma after an epidural blood patch. Int J Obstet Anesth. 2012 Apr;21(2):189–92.
Diaz JH. Permanent paraparesis and cauda equina syndrome after epidural blood patch for postdural puncture headache. Anesthesiology. 2002 Jun;96(6):1515–7.
Foster P. ACTH treatment for post-lumbar puncture headache. Br J Anaesth. 1994 Sep;73(3):429.
Kshatri AM, Foster PA. Adrenocorticotropic hormone infusion as a novel treatment for postdural puncture headache. Reg Anesth. 1997 Oct;22(5):432–4.
Collier BB. Treatment for post dural puncture headache. Br J Anaesth. 1994 Mar;72(3):366–7.
Cánovas L, Barros C, Gómez A, Castro M, Castro A. Use of intravenous tetracosactin in the treatment of postdural puncture headache: our experience in forty cases. Anesth Analg. 2002 May;94(5):1369.
Carter BL, Pasupuleti R. Use of intravenous cosyntropin in the treatment of postdural puncture headache. Anesthesiology. 2000 Jan;92(1):272–4.
Gupta S, Agrawal A. Postdural puncture headache and ACTH. J Clin Anesth. 1997 May;9(3):258.
Hakim SM. Cosyntropin for prophylaxis against postdural puncture headache after accidental dural puncture. Anesthesiology. 2010 Aug;113(2):413–20.
Zeger W, Younggren B, Smith L. Comparison of cosyntropin versus caffeine for post-dural puncture headaches: A randomized double-blind trial. World J Emerg Med. 2012;3(3):182–5.
Hanling SR, Lagrew JE, Colmenar DH, Quiko AS, Drastol CA. Intravenous Cosyntropin Versus Epidural Blood Patch for Treatment of Postdural Puncture Headache. Pain Med. 2016 Mar 25;
Terenius L. Effect of peptides and amino acids on dihydromorphine binding to the opiate receptor. J Pharm Pharmacol. 1975 Jun;27(6):450–2.
Terenius L, Gispen WH, De Wied D. ACTH-like peptides and opiate receptors in the rat brain: structure-activity studies. Eur J Pharmacol. 1975 Oct;33(2):395–9.
Plomp GJ, Van Ree JM. Adrenocorticotrophic hormone fragments mimic the effect of morphine in vitro. Br J Pharmacol. 1978 Oct;64(2):223–7.
Rucklidge MWM, Yentis SM, Paech MJ. Synacthen Depot for the treatment of postdural puncture headache. Anaesthesia. 2004 Feb;59(2):138–41.
Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073–93.
Rucklidge OMWM. All patients with a postdural puncture headache should receive an epidural blood patch. International Journal of Obstetric Anesthesia. 2014 May;23(2):171–4.
Aya AG, Mangin R, Nouvellon E, Robert C, Ferrer JM, Eledjam JJ. [Dural puncture in obstetric analgesia. Epidemiologic features and therapeutic management]. Ann Fr Anesth Reanim. 2001 Nov;20(9):757–62.

SPIRITchecklistEsybreche14112019.pdf

Download PDF

Journal Publication

published 08 Jan, 2020

Read the published version in Trials →

Review #1 received at journal
22 Nov, 2019
Editorial decision: Minor revision
22 Nov, 2019
Editor assigned by journal
15 Nov, 2019
Reviewers invited by journal
15 Nov, 2019
Reviewer #1 agreed at journal
15 Nov, 2019
Submission checks completed at journal
14 Nov, 2019

You are reading this older preprint version

Read the latest preprint version →

Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): A study protocol for a randomized controlled trial

Status:

Journal Publication

Version 2

Abstract

Figures

Background

Methods/Design

Discussion

Conclusion

List of abbreviations

Declarations

Bibliography

Supplementary Files

Status:

Journal Publication

Version 2