Comparison of intravenous or perineural dexamethasone decrease rebound pain after ropivacaine single popliteal sciatic nerve combined with femoral nerve block for ankle fracture: a prospective, randomized, placebo-controlled trial

doi:10.21203/rs.3.rs-1426608/v1

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Comparison of intravenous or perineural dexamethasone decrease rebound pain after ropivacaine single popliteal sciatic nerve combined with femoral nerve block for ankle fracture: a prospective, randomized, placebo-controlled trial

https://doi.org/10.21203/rs.3.rs-1426608/v1

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Introduction Single nerve block provides excellent analgesia, but rebound pain after the nerve block disappears has gradually attracted people’s attention. Perineural dexamethasone has been shown to extend the duration of a single nerve block and reduce rebound pain. However, no studies have compared the effect of reducing rebound pain between the two. The hypothesis was tested that perineural or intravenous would have an equivalent effect on prevent the rebound pain after nerve block.

Methods We recruited 135 patients with ankle fractures scheduled for open reduction and internal fixation (ORIF), each of whom received a single sciatic-popliteal nerve block in combination with a single nerve block. Patients were randomized into three group: 40ml ropivacaine 0.375% (C); 40ml ropivacaine 0.375% with perineural dexamethasone 10mg(PN); 40ml ropivacaine 0.375% with intravenous dexamethasone (IV). The primary outcome was the incidence of rebound pain.

Results The incidence of rebound pain was significantly lower in group PN (11%)and group IV(17.8%), compared with group C(42.2%). Both Groups PN and IV had reduced pain score, reduced postoperative consumption of analgesics and improved the quality of sleep on the night of surgery compared with Group C.

Conclusions Dexamethasone 10mg can prevent the rebound pain after combined femoral nerve and sciatic nerve blocks nerve block, which has nothing to do with the way of dexamethasone.

Trial registration number www.chictr.org.cn/index.aspx ChiCTR2100049075

Dexamethasone

Nerve block

Rebound pain

Postoperative analgesia

Ankle fracture

Fracture patients are often accompanied by acute postoperative pain. Benefits from excellent analgesic effect, peripheral nerve block (PNB) is widely used in limb orthopaedic surgery, it can reduce postoperative opioid consumption and is considered to be an essential part of multimodal postoperative analgesia.[1] However, Rebound pain after PNB has been paid more and more attention in recent years.[2] Compared with patients who did not receive PNB, patients who received PNB experienced sound analgesic effects after surgery. Still, when the analgesic effect of PNB has dissipated, some patients suffer more pain. Currently, there is no uniform definition of rebound pain. It is described as the patient feeling severe pain in a short time after the effect of PNB wear off.

In some studies, perineural administration of dexamethasone as an adjuvant could be prevent rebound pain after PNB[3]. In the operating room, anesthesiologists usually add dexamethasone to local anaesthetics to prolong the duration of single-shot PNB. However, this view has been challenged; some clinical trials have been founded that intravenous dexamethasone can extend the time of PNB as well as peripheral administration.[4–6] And simultaneously, in a study of healthy volunteers, it has been found that no matter what method of dexamethasone administration is it can prolong the block time, which makes people speculated whether the mechanism of dexamethasone extending the PNB effect is the systemic anti-inflammatory effect.[7] Therefore, We hypothesized whether intravenous dexamethasone could also prevent rebound pain.

At present, there is no study comparing the effects of different modes of administration of dexamethasone on the prevent rebound pain after PNB. We hypothesized that dexamethasone preventing rebound pain after single-shot PNB regardless of the mode of administration. Therefore, this study intends to conduct a prospective, randomized, placebo-controlled trial to observe the effects of different routes of administration of dexamethasone on rebound pain, and then explore the mechanism of postoperative rebound pain, optimize orthopaedic postoperative analgesia solution.

Study design and participants

We included patients for open reduction and internal fixation(ORIF) of an ankle fracture between July 2021 and December 2021. Patients ages ≥ 18 years with ASA physical status ⅠཞⅡ, Eligible fracture patterns were bimalleolar or trimalleolar. Exclusion criteria included: Body mass index ≥ 35kg/m²; Medical contraindication to PNB (e.g. coagulopathy, allergy to local anaesthetics, or localized infectious and neurologic disease) and dexamethasone; Multiple injuries or fractures; Time from fracture to operation༞5 days; Cognitive or psychiatric dysfunction causing unable to use intravenous analgesia pump and inability to verbally communicate pain scores; Pregnancy; Receiving chronic pain treatment, having drug abuse history and having respiratory or cardiac disease.

Randomization

All patients were randomly divided into three-treatment groups by random number table: group C (0.375% Ropivacaine), group PN(0.375% Ropivacaine and perineural 10mg of dexamethasone), group IV(0.375% Ropivacaine and i.v. 10mg of dexamethasone). All patients, anaesthesiologist and researchers responsible for data collection were unaware of the group allocation.

Anaesthesia

After the patient entered the operation room, the peripheral vein was opened and inhalation oxygen with a facemask. Routine intraoperative monitoring was applied, including oxygen saturation (SpO₂ ), electrocardiography (ECG), and non-invasive blood pressure (NBP). Sedated with i.v. midazolam (2 mg) and sufentanil (3 µg) .

All patients received nerve blocks under ultrasound guidance. The patients were placed in a supine position, after skin disinfection and infiltration with lidocaine 1%, the ultrasound probe (line probe, frequency 5-10MHz,sonosite company, USA) was placed in the inguinal region. Capturing the femoral nerve A 21-gauge,50-mm inserted needle was inserted using an in-plane technique; after negative aspiration, inject 20 ml local anaesthetics. Then the patients were placed in the lateral decubitus position, and the probe was placed in the popliteal fossa with a short-axis; identify separate tibial and common peroneal nerves, and movement of the probe proximally brought tibial and common peroneal nerves together to form the sciatic nerve at a variable point, above the popliteal crease. After skin disinfection and infiltration with lidocaine 1%, the needle was inserted in-plane from the lateral end of probe and injected with a total of 20 ml local anaesthetics. All operations were performed by anesthesia residents under the supervision of an experienced anaesthesiologist.

General anaesthesia induced: Sequential intravenous injection midazolam 0.02–0.08 mg/kg, propofol 1.5-2mg/kg, sufentanil 0.2–0.4µg/kg and cisatracurium 0.1-0.2mg/kg. After the patient's consciousness disappears, place laryngeal mask and conduct mechanical ventilation. Anesthesia maintain: propofol 3-5mg·kg-1·h-1 and remifentanil 0.1–0.3µg·kg-1·h-1. Intermittent intravenous injection cisatracurium maintain muscle relaxation. No patients received additional narcotics, local anaesthetics, or dexamethasone intraoperatively. 30 minutes before the end of the operation. Palonosetron 0.25mg was given intravenously 30 minutes before the end of surgery to prevent postoperative nausea and vomiting.

Postoperative management

All patients were connected patient-controlled intravenous analgesia (PCIA) pump(1–2µg/kg sufentanil; flow rate:2ml/h; bolus: 0.5ml; lockout time: 15 mins). When they felt nerve block was ineffective, the patients were instructed to open PCIA independently, and they could press the button for the PCIA bolus when experiencing severe pain. If the patient needed more analgesics in the ward, intravenous injective ketorolac 30mg.

Outcome assessment

Through the pain questionnaire, recorded the patient's the time of the first appearance of pain and the pain score at 6, 12, 24, 36 and 48h. We used the numeric rating scale (NRS 0–10 points) to assess patients pain levels. The number of PACI boluses and additional analgesic doses were recorded by the patient within 3 days after surgery. Collected the adverse reactions such as Postoperative nausea and vomiting; postoperative infection. The quality of sleep before injury was used as a criterion; subjective sleep quality was assessed using a numeric rating scale (0–10 points). Patients’ satisfaction was evaluated by questioning whether they would receive the same analgesic method in the future.

The primary outcome was the incidence of rebound pain after postoperative, which was defined as an increase from well-controlled to severe pain (NRS ≥ 7)of resolution of the PNB.

Sample size estimation and statistical analyses

The sample size of the study was calculated using the PASS version 15. According to the published literature, the incidence of rebound pain is 50%; we aimed to reduce the rebound pain by 30% in Group IV or PN compared with Group C. 36 patients were calculated to be needed in each group (power = 80% and α = 0.05). Considering the incidence of patient dropout, we planned to 40 patients in each group.

Kolmogorov–Smirnov test was used to assess distribution of the variables. Continuous data with normality were presented as mean ± standard deviation (SD) and compared by One-way ANOVA. Continuous data with abnormality was presented as median (interquartile range, IQR) and compared by Kruskal-Wallis test. Categorical data were presented as frequency (percentage) and compared by chi-square test or Fisher’s exact test. Multiple comparison between three groups were used Holm-Bonferroni method.

All statistical analyses were performed with IBM SPSS software version 25.0 (SPSS Inc, Chicago, IL). The significance level for each hypothesis was a two-sided P < 0.05.

We assessed 142 patients for eligibility in this study; Seven patients were excluded because they were not meet the inclusion criteria. Finally, 135 patients were enrolled. Figure 1 presents the group allocation process according to the Consolidated Standards of Reporting Trials statement.

There were no statistically differences between the three groups regarding the baseline demographic, anaesthetic or surgery characteristics (Table 1).

Dexamethasone decreases the incidence of rebound pain, independent of the mode of administration. The incidence of rebound pain was significantly decreases in both the Group PN (11.1%) and Group IV (17.8%) compared with the Group C (44.2%, P<0.001). There was has statistically significant differences between Groups C and PN (P<0.001), Groups C and IV (P<0.01), but not between Groups PN and IV (P = 0.954).

The duration of sensor block (mean[95%]) was prolonged by perineural dexamethasone (22 hours [20, 26]) compared with Group C (11 hours [10, 13.5]; P<0.001), IV dexamethasone prolonged sensor block time(21 hours [19, 24]) compared with Group C (P<0.001). There was no significant difference in sensor block duration between the perineural and IV dexamethasone groups(Fig. 2).

Patients in groups PN and IV recorded less pain at 12–36 hours postoperatively compared with those in Group C (P<0.01); no difference pain was reported between the Groups PN and IV. The three groups had similar pain scores at all the other time points. The total number of times the patient pressed the analgesia pump and rescue analgesia increased in Group C than in Groups PN and IV (P<0.01), no statistically differences between Groups PN and IV (Table 2).

During the first night, there was a significant lower sleep score in Group C compared with Groups PN and IV (P = 0.002; Fig. 3). There were no differences in patient satisfaction (P = 0.06). There were no differences in the incidence of postoperative nausea and vomiting. Finally, none of the patients reported any block-related complications and postoperative infection events.

Table 1

Demographic, anesthetic or surgery characteristics
	Group C (n = 45)	Group PN (n = 45)	Group IV (n = 45)	P value^*
Age(SD), yrs	44.2(12.9)	43.3(11.1)	45.1(14.9)	0.808
Sex, n(%)				0.902
male	32 (71.1)	31 (68.9)	30 (66.1)
Female	13 (28.9)	14 (31.1)	15 (33.9)
BMI(SD),kg/m²	25.1(3.0)	25.7(3.7)	25.8(3.0)	0.470
ASA physical status, n(%)				0.293
Ⅰ	27 (60.0)	32 (71.1)	25 (55.6)
Ⅱ	18 (40.0)	13 (28.9)	20 (44.4)
Duration of surgery(SD) ,min	79.2(19.3)	79.5(27.6)	81.8(21.7)	0.847
Duration of anesthesia(SD), min	100.0(20.8)	107.4(26.9)	106.9(22.2)	0.256
Fracture type,n(%)				0.240
Bimalleolar	33 (73.3)	30 (77.7)	37 (82.8)
Trimalleolar	12 (26.7)	15 (33.3)	8 (17.8)
Preoperative pain (IQR), NRS	3.2(1.3)	2.9(1.1)	3.1(1.3)	0.583
ASA, American Society of Anesthesiologists; BMI, body mass index; NRS, numeric rating scale;
^*P value for comparison between Group C ,Group PN and Group IV.

Table 2

Rebound pain, postoperative NRS for pain and analgesia related data
	Group C (n = 45)	Group PN (n = 45)	Group IV (n = 45)	P value ^*,†
Mean pain score (IQR),NRS
6 hours	0	0	0	>0.999
12 hours	2 (0, 4)	0	0	<0.001
18 hours	4 (3, 5)	0 (0, 0)	0 (0, 2)	<0.001
24 hours	4 (3, 5)	0 (0, 0)	0 (0, 2)	<0.001
36 hours	3 (3, 4.5)	3 (0, 4)	3 (2, 4.5)	<0.01
48 hours	2 (2, 3)	3 (2, 3)	3 (2, 3)	0.362
Duration of analgesia(IQR), hours	11 (10, 13.5)	22 (20, 26)	21 (19, 24)	<0.001
Incidence of rebound pain, n (%)	19(42.2)	5(11.1)	8(17.8)	<0.001
Duration of pain in patients experiencing rebound pain(IQR), hours	3.30 ± 1.11	4.50 ± 1.12	3.56 ± 1.21	0.131
Number of times the patient pressed the analgesia pump(IQR)	4 (2, 7)	2 (0, 3)	2 (1, 3)	<0.001
Rescue analgesia(SD)	0.51 ± 0.66	0.13 ± 0.40	0.27 ± 0.54	<0.01
Sleep score(IQR),NRS
Night of surgery	6 (4, 7)	7 (6, 8)	7 (6, 8)	<0.01
Night of POD1	8 (7, 8)	8 (7, 9)	8 (7, 8.5)	0.733
Patient satisfaction(IQR),NRS	8 (7, 9)	8 (8, 9)	8 (8, 9)	0.060
Postoperative nausea and vomiting, n (%)	9 (20.0%)	6 (13.3%)	4 (8.9)	0.353
ASA, American Society of Anesthesiologists; NRS, numeric rating scale.
^*P value for comparison between Group C ,Group PN and Group IV.
^†One-way ANOVA was used to compare means, Kruskal-Wallis test was used to compare medians, andχ2 test was used to compare proportions or Fisher’s exact test

In this study, we found that intravenous or perineural dexamethasone 10mg have equally effective in preventing rebound pain after PNB. As an adjuvant, dexamethasone is added to ropivacaine to prevent rebound pain from 42.2–11.1%, and prolong the analgesic time of PNB. This is concordant with the results in other papers. [3] However, in this study, we demonstrate that perineural or intravenous dexamethasone reduces rebound pain after nerve block in ankle surgery, regardless of route of administration.

There are many previous studies investigating the effect of adding dexamethasone to PNB on rebound pain, but little has been reported on the different modes of administration. In a retrospective cohort analysis, investigators found that intravenous dexamethasone can reduce rebound pain. [2] So this study intends to observe the effect of different administration methods of dexamethasone on rebound pain after PNB. At present, most reports on rebound pain focus on upper limb surgery. Rebound pain in upper limb surgery is higher than that in lower limb surgery.[2] Although we cannot explain this phenomenon yet, it is necessary to explore further the rebound pain in lower limb orthopaedic surgery. The ankle is not innervated by a single nerve, and considering the use of thigh tourniquets during the operation, we chose the femoral nerve combined with the sciatic nerve block.

Patients often suffer severe pain after orthopaedic surgery. If the pain is without timely and effective treatment, acute postoperative pain might transform into chronic.[8] Opioid-based treatment has become a mainstay of postoperative pain management in strategies to prevent the progression of acute pain to chronic pain. Although opioids are effectively treat acute and chronic pain, they are strongly associated with adverse reactions.[9] On top of that, opioids are one of the leading causes of drug overdose deaths[10]. Benefits from excellent analgesic effect and popularization of ultrasound visualization technology, PNB is widely used in orthopaedic operations, it is considered an excellent tool for reducing postoperative pain and opioid consumption. However, the occurrence of rebound pain may offset this benefit. M. J. Henningsen and colleagues in a qualitative study of patients’ experience after PNB in ankle fracture surgery, despite pre-emptive Nonsteroidal drugs, some patients did experience excruciating pain when PNB wore off, it described as burning characteristics.[11] An increasing number of surgical procedures are performed on an outpatient basis. BNP provides a near-painless experience for a longer period of time after surgery, allowing early discharge of outpatients. However, the occurrence of rebound pain may make the patient experience unbearable pain. Postoperative pain is one of the most commonly reported reasons for postoperative readmissions.[12] When ambulatory surgery patients return home, they are often confronted with sudden severe pain without the guidance of professional doctors and appropriate analgesics, which may increase the readmission rate of discharged patients, waste medical resources and increase the burden on society. Or in the case of unbearable pain, the patient ingests excessive painkillers in a short time, resulting in drug overdose, bringing a series of adverse consequences. Although in our survey of patient satisfaction after surgery, patients are satisfied with our anaesthesia and postoperative analgesia program, we cannot ignore this phenomenon. The rebound pain after PNB may be underestimated by many surgeons and anaesthetists.

The use of dexamethasone as an adjuvant to reduce postoperative rebound pain has been demonstrated in previous studies.[3, 13] In exploring the mechanism of rebound pain,[14] Ke An and colleagues in animal study founded transient rebound hyperalgesia to thermal after the resolution of mouse sciatic block with bupivacaine, and bupivacaine-induced axon degeneration and Schwann cell response in early phase; At the same time, they demonstrated the perineural dexamethasone could prevent neurotoxicity and rebound hyperalgesia after nerve block. It is important to note that the authors suggest that perineural rather than the systemic application of dexamethasone may prevent rebound and pain. Although the local anaesthetic we use is not bupivacaine, there are similar reports of ropivacaine.[15] Chemical injury can induce fibre degeneration and alterations and composition, lead to ectopic firing, faulty signal transmission and neurological pain.[16] Regional anaesthetics are widely used in clinical practice. Current evidence suggests that perioperative nerve injury is mostly unrelated to regional block technique. However, next to these beneficial effects, local anaesthetics exhibit time and dose-dependent toxicity to various tissues, including nerves.[17] An earlier study showed that clinically used concentrations of local anaesthetic solutions could alter perineurial permeability, producing changes in the endoneurial environment that are associated with neurotoxic injury.[18] Therefore, the neurotoxicity of local anesthetics is perhaps one of the underlying mechanisms of rebound pain after PNB. Perineural dexamethasone can prevent chemical damage from local anesthetics, thereby preventing rebound pain.

Whereas, according to our trial results, systemic application of dexamethasone can also achieve this effect. The addition of dexamethasone as an adjuvant to local anaesthetics can prolong the duration of PNB, and is widely used in clinical practice. The current view is that dexamethasone can stimulate glucocorticoid receptors on the neuronal membrane, increasing expression of inhibitory potassium channels and decreasing excitability of neuronal transmission; localized vasoconstriction and systemic anti-inflammatory.[19] However, this view has been challenged recently, many reports have questioned the perineural dexamethasone prolongs the acting time of nerve block mechanism, intravenous dexamethasone can also achieve the same effect. ^{2 3} On the study of the local dexamethasone on rat sciatic nerve electrophysiology, behaviour, and histologic effect, found that although dexamethasone can temporarily reduce conduction, but the long-term effects of sciatic nerve was not significant.[20] Among the local anaesthetic adjuvants that can be added, only epinephrine appears in the instructions, and other drugs are off-label. In view of inconsistent evidence supporting perineural or intravenous administration, the prevailing view is to recommend the systemic approach to local anaesthetic adjuvants.

In addition to its prominent role to preventing postoperative nausea and vomiting, perioperative use of glucocorticoids has been administered as adjunct in multimodal regimes for pain control. In recent clinical guidelines, dexamethasone is also listed as part of multimodal analgesia.[21] Current meta-analysis suggests that intravenous dexamethasone used can significantly reduce opioid use and postoperative pain after total knee arthroplasty. [22] Dexamethasone exerts anti-inflammatory effects by inhibiting activated glucocorticoid receptors and transcription factor nuclear factor-kappa B and activator protein-1, which are involved in the expression of pro-inflammatory genes. [23] Preoperative dexamethasone can reduce inflammatory markers such as interleukin-6, cortisol and C-reactive protein in 24 h after surgery.[24] Levels of inflammatory markers were associated with postoperative pain. Most of the postoperative pain is acute nociceptive pain. Tissue damage causes inflammation, and the release of inflammation and pain-causing mediators reaches a peak within 24 hours,[25] which aggravates ischemia, hypoxia and oedema in the primary lesion.[26] However, the duration of the nerve block cannot completely cover this "time window". In addition, there is a hypothesis that has not yet been proven,[27] Endogenous opioids are present in the central and peripheral nervous systems. The endogenous opioid system can be activated by stressors, including surgical pain, but a single-shot nerve block theoretically suppresses this effect. When the effect of the local anaesthetic wears off, potentially leaving the patient vulnerable to severe pain. This may explain that rebound pain usually lasts only a few hours, and there were no long-term complications when the symptoms subsided. Therefore, we suspect that the occurrence of rebound pain may be related to the failure of other analgesic measures to bridge in time.

This study have some limitations that should be interpreted. First, according to our research, we assume that the possible mechanism of perineural injection of dexamethasone to prevent rebound pain is the systemic effect after local drug absorption. However, systemic application of glucocorticoids also has some impact on peripheral nerve fibres. Although there is a significant difference in drug concentration between systemic and local applications, we cannot rule out this effect. Second, postoperative pain and sleep quality are subjective. And considering that patients need to rest after surgery, we arrange the follow-up time every morning. Help the patient to recall the pain level in the previous time through conversation, so the data we collect may be inaccurate. Third, we all use thigh tourniquets during surgery, which may aggravate postoperative pain levels and affect measurement accuracy.

In summary, intravenous or perineural dexamethasone can extend the duration of PNB, prevent the rebound pain, thus reduce postoperative analgesic drug consumption, improve postoperative night sleep quality, and there is no difference between the two modes of administration.

Conflicts of Interest:

The authors declare no conflicts of interest

Funding:

Hebei Province technology Innovation guide Project Science and Technology Winter Olympics special project (19977790D); Hebei Provincial government funded the specialty capacity building and specialty leader training program;

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No competing interests reported.

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Comparison of intravenous or perineural dexamethasone decrease rebound pain after ropivacaine single popliteal sciatic nerve combined with femoral nerve block for ankle fracture: a prospective, randomized, placebo-controlled trial

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