Effect of Preoperative Single-Dose Methylprednisolone Administration on Early Postoperative Pain Following Retrograde Intrarenal Surgery

doi:10.21203/rs.3.rs-3239948/v1

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Effect of Preoperative Single-Dose Methylprednisolone Administration on Early Postoperative Pain Following Retrograde Intrarenal Surgery

https://doi.org/10.21203/rs.3.rs-3239948/v1

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Aim:To evaluate the effect of preoperative single-dose methylprednisolone use on postoperative early pain after retrograde intrarenal surgery (RIRS).

Material and Metod: Patients who had a 10–20 mm solitary kidney stones and underwent RIRS procedures were included in this prospective cohort study between February 2022 and May 2023. Patients who were administered methylprednisolone at a dose of 1mg/kg preoperatively were included in group 1 (n: 31), and the other first 90 patients who met the inclusion criteria and did not receive methylprednisolone before surgery were included in group 2 (n:90). Demografic data, features of stone, postoperative pain at 1, 6, 12, 18, and 24 hours, the need for analgesics, changes of serum glucose levels and, the prevalence of postoperative fever were compared.

Results: Age, sex, stone laterality, localization, size, and Hounsfield Unit, modified Satava scores, stone-free status, duration of the RIRS procedure, and duration of the Ureteral Access Sheath were found to be similar between groups. VAS scores at postoperative 1, 6, 12, 18, and 24 hours were found to be statistically significantly lower in gourp 1 (p=.001, p=.001, p=.001, p=.001 and p=.001, respectively). Similarly, postoperative analgesic requirements were found to be significantly lower in group 1 (p=.048) with a similar postoperative fever rate and changes of serum glucose levels between groups.

Conclusion: Giving a single dose of metylprednisolone at a dose of 1mg/kg preoperatively during the RIRS procedure is safe and effective at preventing early pain and the need for analgesics after the RIRS procedure.

Analgesic

Kidney Stone

Metylprednisolone

Pain

RIRS

Retrograde intrarenal surgery (RIRS) has become one of the most common endourological procedures for the treatment of kidney stones, with a greater rate of success as a result of technological advancements in the field of endourology in recent years[1, 2]. RIRS is generally considered to be a safe procedure, and serious complications following the procedure are rare [3].

Ureteral access sheaths (UAS) are commonly used during the RIRS procedure. Because the UAS usually has a large diameter, it compresses the ureteral wall from the inside during the operation, which may negatively affect the blood supply of the ureter[4]. We think that after the removal of the UAS after the surgery, ischemia-reperfusion injury may occur with the re-perfusion that starts after the compression effect on the ureteral wall ends. Pulitanò et al. showed that preoperative single-dose steroid administration seems to represent a valid strategy if temporary ischemia is required during surgery, in order to reduce complications caused by ischemia-related organ dysfunction [5].

Steroids may block the cyclooxygenase and lipoxygenase pathways of the inflammatory process, which decreases the levels of inflammatory mediators such as prostaglandins and leukotrienes [6]. Additionally, steroids may inhibit the release of neuropeptides and reduce the level of bradykinin in tissues, both of which increase the sensation of injury in surgical areas [7]. Methylprednisolone, a type of corticosteroid, increases the synthesis of anti-inflammatory mediators and decreases the production of pro-inflammatory mediators, preventing postoperative edema at the surgical site [8].

The literature is growing currently, with studies focused on complications following RIRS. However, only a few studies have investigated postoperative procedural pain [9]. To the best of our knowledge, there is no publication about the effect of steroid treatment on postoperative pain after the RIRS procedure. With this study, we aimed to evaluate the effect of preoperative single-dose methylprednisolone use on postoperative pain after RIRS due to steroids effects on inflammatory mediators and ischemia-reperfusion injury.

After the Institutional Review Board's approval (KAEK/2022.01.18) was obtained, a prospective cohort study was designed between february 2022 and may 2023 at our high volume referral hospital. After patients were consented to the study and informed about various treatment options, possible complications, and the potential need for a staged or ancillary procedure, all procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards and this study was designed according to the STROCSS 2021 criteria [10].

Patients who were over 18 years old and underwent RIRS for solitary kidney stones 10–20 mm in size were included in the study. Patients were excluded if they had multiple or bilateral stones, stone diameters different from 10–20 mm, ureteral stones, pregnancy, diabetes mellitus, a history of stone surgery or extracorporeal shock wave lithotripsy (ESWL) in the previous 6 months, any history of urine diversion for an existing stone (such as with a nephrostomy catheter or Double-J stent), a history of urinary tract infection in the last 1 month, a modified Satava Score of grade 2 and above during the procedure, any neurological disease and use of any neuropsychiatric medication, use of analgesics within 24 hours before surgery (such as paracetamol or non-steroidal anti-inflammatory drugs), (if used) a perioperative methylprednisolone dose different from 1 mg/kg, or used other types of the steroid (such as dexamethasone, cortisone, and prednisone), and did not use an UAS during the procedure.

Each of the patients underwent a standard preoperative evaluation, which included urinalysis, urine culture, complete blood count, serum biochemistry, and coagulation profile. In all cases, preoperative non-contrast CT scan is performed to assess the anatomy of the collecting system and to identify the size and location of the kidney stone.

The patients were divided into 2 different groups according to the preoperative methylprednisolone administration at a dose of 1 mg/kg. The indication for steroid use (such as anti-edema after difficult intubation, and presence of a suspected allergic reaction) and the dose of the methylprednisolone were blindly administered by the anaesthesiologist just before the operation. Patients who were administered preoperative methylprednisolone were included in the first group and recorded as group 1 (n:31). Since the effect level and half-life of other steroid types are different, only patients who received methylprednisolone at a dose of 1mg/kg preoperatively were included in the study. According to the order of hospital admission, the first 90 patients who met the inclusion criteria and did not receive methylprednisolone before surgery were included in the study as the second group and were recorded as group 2 (n:90).

RIRS was either performed under general or spinal anesthesia. Initially, a 6,5–8,5F semi-rigid ureteroscope (Richard Wolf, IL, US) was used to evaluate for the presence of ureteral pathology and ureteral stones. A 6-9.9F flexible reusable URS (Flexible Ureterorenoscope, Richard Wolf, IL, US) were used with an 12F UAS (Flexor® Ureteral Access Sheath, Cook®, Bloomington, IN, USA)) for the all patients. The stone was fragmented using with a Ho: YAG laser (MegaPulse 70+®, Richard Wolf, IL, US). A 4.8F/26 cm double-J stent was placed in all cases after the procedure. In all patients, perioperative complications were evaluated with the modified satava score [11].

Postoperative 1st day, X-ray were used to check stone-free status and stent localizationfor all patients. Stone-free status was defined as a presence of asymptomatic residual stone < 4 mm. Patients were usually discharged on postoperative 1st day.

Demographic parameters (such as age and sex), stone size (mm), the Hounsfield Unit (HU), and locations (renal pelvis or calyces), preoperative pain and serum glucose level, peroperative (use of methylprednisolone, duration of procedure, duration of UAS, modified satava scores) and postoperative data (pain, need for analgesic, precence of postoperative fever, stone-free status, and serum glucose level) were recorded for all patients.

Visual Analog Scale (VAS)

The VAS is used to assess the severity of a patient’s pain. It is recorded between 0 to 10 (0 = no pain, and 10 = most severe pain). Patients were asked about the pain they perceived. The value shows the severity of pain perceived by the patient [12].

For all patients, VAS scores were recorded at preoperative and postoperative 1, 6, 12, 18, and 24 hours to evaluate the pain status.

Statistical assessment of data

In this study, data obtained from personal information forms and scales were transferred to a computer by SPSS (Statistical Package Programme for Social Sciences 22.0) program, and the data were analyzed by this program. The data obtained were presented as arithmetic mean ± standard deviation, while quantitative data were presented as number and percentages (%). Each group was tested with Kolmogorov–Smirnov test to investigate the normal distribution of the obtained data. Mann–Whitney U-test was used for data because of stone size, duration of the procedure, VAS scores of the preoperative and postoperative 1, 6, 12, 18, and 24 hours were found without normal distribution. T-Test was used for data because of age and the Hounsfield unit of stone were found with normal distribution. The presence of postoperative fever and postoperative analgesic requirement analyzed using the Chi-Square test. The level of significance was determined as p < 0.05.

Patient demographic data and comparisons between two groups are shown in Table 1. Age and sex were not found to different between the groups (p = .345, p:.051, respectively). Stone laterality, localization, size, and HU were found to be similar between groups (p = .867, p = .063, p = .952, and P = .350, respectively). There was no statistically significant difference in modified Satava Scores and Stone-Free status between the groups (p:.125, p:.456, respectively). The duration of the RIRS procedure, the duration of the UAS, change in serum glucose level and, the postoperative fever rate were found to be similar between groups (p = .546, p = .231, p:.054, p:.304, respectively) (Table 1).

Table 1

Patient’s demographics and comparison of two groups
	Group 1 (n = 31)	Group 2 (n = 90)	p value
Age (years), mean ± SD (range)	42 ± 9,9 (24–54)	44,5 ± 13,6 (18–58)	0.345*
Sex, n			0.051***
Female/Male	7 / 24	38 / 52
Stone laterality, n			0.867***
Left/Righ	16 / 15	42 / 48
Stone localization, n			0.063***
Renal pelvis / calyces	25 / 6	63 / 27
Stone size (mm), mean ± SD (range)	15,2 ± 3,2 (10–20)	15,3 ± 2,9 (10–20)	0.952**
The Hounsfield unit of stone (HU), mean ± SD (range)	1111 ± 310 (500–1467)	1048 ± 325 (411–1600)	0.350*
Duration of RIRS (min), mean ± SD (range)	43,7 ± 12,2 (20–60)	44,8 ± 12,1 (20–60)	0.546**
Duration of Ureteral Access Sheath, mean ± SD (range)	36,5 ± 14,3 (15–52)	38,3 ± 13,4 (15–55)	0.231**
Modified Satava Score (Grade 1), n (%)	5 (16,1)	14 (15,5)	0.125***
Stone-free status, n (%)	28 (90,3)	80 (88,8)	0.456***
Serum Glucose level (mg/dL), mean ± SD (range)
Preoperative	94,8 ± 15,7 (79–129)	96,5 ± 13,3 (78–129)	0.321**
Postoperative 24th hour	109,4 ± 13,2 (78–131)	103,6 ± 12,5 (79–132)	0.038*
Change	14,6 ± 17,2 (-33–42)	7,1 ± 20,5 (-46–38)	0.054**
Postoperative fever, n (%)	2 (6,5)	8 (8,8)	0.304***
RIRS: retrograde intrarenal surgery; T test; Mann-Whitney U; ******Chi-Square

However, the mean preoperative pain score of group 1 was found to be higher than group 2, and this difference was not found to be statistically different (p = .088). VAS scores at postoperative 1, 6, 12, 18, and 24 hours were found to be statistically significantly lower in gourp 1 (p = .001, p = .001, p = .001, p = .001 and p = .001, respectively). Similarly, postoperative analgesic requirements were found to be significantly lower in group 1 (p = .048) (Table 2).

Table 2

Preoperative and postoperative VAS scores and analgesic requirement of two groups
	Group 1 (n = 31)	Group 2 (n = 90)	p value
Preoperative pain score (VAS), mean ± SD (range)	4,13 ± 0,8 (3–6)	3,77 ± 1,1 (2–6)	0.088*
Postoperative pain scores (VAS), mean ± SD (range)
1st hour	2,61 ± 0,8 (1–4)	4,37 ± (2–6)	0.001*
6th hour	2 ± 1 (1–5)	4,13 ± 1,1 (1–8)	0.001*
12th hour	1,45 ± 1,1 (0–4)	3,81 ± 1 (1–7)	0.001*
18th hour	0,87 ± 0,6 (0–2)	2,08 ± 0,7 (1–4)	0.001*
24th hour	0,52 ± 0,6 (0–2)	1,48 ± 0,7 (0–4)	0.001*
Postoperative analgesic requirement, n (%)	1 (3,2)	6 (6,7)	0.048**
VAS: visual analog scale; Mann-Whitney U; *Chi-Square

Minimally invasive treatment options for renal stones are now increasingly being used as a result of improvements in endoscopic techniques. For this reason, RIRS, which is minimally invasive and more comfortable for patients with high success rate compared to other treatment options (e.g., percutaneous nephrolithotomy, open surgery), is gaining popularity day by day [13].

Several complications may occur after RIRS, even though it is known as a minimally invasive technique, and it is well known that major complications classified as Satava III or Clavien III-V are found to be rare with the RIRS procedure [9]. Most of the studies have focused on only the serious complications of RIRS in the current literature [2]. As a result of this, there are only a few studies on postoperative pain as a complication. So postoperative patient comfort and pain management have not been standardised regarding efficacy and complications in kidney stones treatment. For this reason, we aimed to evaluate the effect of peroperative single-dose methylprednisolone using on postoperative pain after RIRS procedure.

Postoperative pain may be an important issue for patients undergoing any type of urological procedure. The preferred treatment for kidney stones has been shown to have an possible effect on postoperative pain. Singh et al. showed that the post-operative pain score of the RIRS procedure was significantly higher than that of ESWL [14]. Pain after kidney stone treatment procedures such as percutaneous nephrolithotomy and ESWL has been investigated by other authors, and it is known that regardless of the preferred treatment, the level of pain experienced by the patient has an effect on the need for postoperative analgesia and patient comfort [15]. In another study, despite other possible complications, pain was also found to be an important complication and was found to be the main reason for re-admission to the hospital after ureteroscopy [16].

The etiology of early postoperative pain after RIRS remains unclear. Acute renal capsule distension, extravasation of irrigation solution, possible ureteral ischemia from pressure from the UAS, and possible obstruction from ureteral edema, blood clots, or stone fragments were all thought to be possible causes of early pain after RIRS. According to the literature, stone-free status was found to be one of the significant factors causing postoperative pain. The rate of residual stone fragments was found to be higher in patients with severe pain [3]. In our study, the stone-free status was found to be similar between the two groups, so it was seen that the stone free status would not affect the result of our study.

A porcine model was used to evaluate the potential acute ischaemic effects of UAS of different diameters. After UAS placement, ureteral blood flow was measured using laser Doppler flowmetry. It was demonstrated that the use of 10F–12F UAS could cause 12–25% decreases in ureteral blood flow; using the larger sheaths could cause up to a 65% decrease in blood flow. The ureteral wall might be exposed to free radicals and subsequent tissue damage due to the reperfusion that occurs after sheath removal [17]. These free radicals and proenflamatuar mediators could explain the mechanism of the postoperative pain. The use of a UAS and the duration of the UAS were found to be associated factors with the post-ureteroscopy need for opioid prescriptions in following RIRS[18]. In contrast, Damar et al. found no significant difference in postoperative pain between using the UAS with or without the RIRS procedure [19]. In another study, no association was found between the size of the UAS and postoperative pain [20]. In order to minimize the possible effect of diameter difference and duration of UAS on postoperative pain, we preferred UAS of the same diameter in all patients in this study, and the duration of UAS was found to be similar in both groups.

The effect of a ureteral J-stent placed at the end of RIRS on postoperative pain is still controversial. It was shown that post-operative pain was significantly reduced with the ureteral J-stent by Torricelli et al [4]. Tanriverdi et al. analyzed the reasons for emergent intervention for refractory pain after unstented URS, and they found that the most common reason was massive ureteral edema, which was seen in 43.6% of unstented patients. As a result, the majority of urologists prefer ureteral stenting to prevent renal colic pain and other obstructive symptoms caused by edema formation [21]. Contrary, there are also studies showing that the presence of a ureteral J-stent does not reduce post-operative pain [3, 22]. Although possible obstruction secondary to post-operative ureteral edema was eliminated by ureteral J-stenting, the fact that pain was still observed in patients shows that the pain is not alone due to the obstructive effect of the edema. This suggests that other mechanisms (such as proinflatuar mediators and ischaemia-reperfusion injury) may be responsible for the development of pain.

Information on the type and dose of corticosteroids used to prevent ureteral edema is not clear. In several major surgical procedures, a single dose of corticosteroids was found to cause an increase in the production of anti-inflammatory mediators, a decrease in the production of pro-inflammatory mediators, a decrease in vascular permeability, and, as a result, a decrease in edema [8]. Similarly, the mechanisms by which steroids can have an effect on pain are not fully understood. It has been demonstrated that systemic steroid administration reduces tissue levels of bradykinin and neuropeptide release from nerve endings, both of which can increase nociception in inflamed tissue. The well-documented inhibition of prostaglandin synthesis by steroids might also contribute to analgesia [23–25]. The anti-inflammatory effects of a single preoperative dose of steroids have been shown to improve postoperative recovery for many major surgical procedures[26]. At a dose of 1 mg/kg, methylprednisolone, a type of corticosteroid, has been shown in many studies to prevent postoperative edema and anaphylaxis[27]. By changing the balance of these mediators and their anti-edema effect, Hamidi et al. have shown that using methylprednisolone at a dose of 1 mg/kg following an uncomplicated URS procedure seems effective at preventing early postoperative edema and pain [28]. Due to the potential ischaemia-reperfusion injury that results from the use of UAS, the ureter wall might be exposed to free radicals. And also, the use of metilprednisolone was found to have a positive effect on ischaemia reperfusion injury [29]. Because of their effects on pro- and anti-inflammatory mediators, administration of a single dose of steroid has been found to reduce postoperative pain, particularly in several surgical procedures. These data also suggest that the analgesic effects of steroids may be secondary to a reduction in local edema [30–32]. Similarly with the current literature, we demonstrated that a single preoperative dose of methylprednisolone significantly reduced early postoperative pain and the need for additional analgesia in the first 24 hours after RIRS. We thought that this effect was a result of the anti-inflammatory and anti-edema effects of the steroid.

Potentially crucial is the timing of steroid administration. It may be too late to fully benefit from the anti-inflammatory effects of steriods if they are administered later than 1 to 2 hours prior to surgery, as the onset of steroid action typically takes 1 to 2 hours and inflammatory responses to surgery are activated immediately after incision[33]. In our study, in order to evaluate this early effect of steroids on postoperative early pain, the results of the patients who were administered steroids by the anesthesiologist within the indications related to anesthesia just before the start of the surgery were evaluated. Therefore, to take advantage of the early effect of steroids in our study, the time between the administration of methylprednisolone and the start of surgery ranged from 0 to 30 minutes.

The risk of infection can be considered as the most important of the side effects of steroid use. However, the relationship between the use of steroids and an increased risk of infection remains unclear. According to the several meta-analyses, no significant difference was found in infection rates between the groups treated with systemic corticosteroids and those not treated with corticosteroids[34, 35]. In addition, Grijalva et al. showed that the risk of infection was associated with the dose of steroids. increased, especially with higher doses of corticosteroids (such as prednisone, doses with > 10 mg/day) [36]. In our study, it was found that the use of a single dose of methylprednisolone had no effect on fever in the first 24 hours postoperatively, which is one of the first signs of infection.

Our study has some limitations. First of all, the limited number of patients in the patient group using methylprednisolone in this study. Secondly, in our study, we focused only on the effect of a single dose of corticosteroids on early postoperative pain, so we did not have data on their long-term effects. In our study, methylprednisolone at a dose of 1 mg/kg was used as a single-dose steroid. Therefore, there are no data on the effects of lower or higher doses. Similarly, the effects of other steroid types, such as prednisolone and dexamethasone, were not analyzed in our study.

According to our study, giving a single dose of metylprednisolone at a dose of 1mg/kg preoperatively during the RIRS procedure is safe and effective at preventing early pain and the need for analgesics after the RIRS procedure. Our findings may be better explained by further studies involving a larger number of patients.

Conflict of Interest: The authors declare that they have no conflict of interest.

Financial Support: The authors declare that they have no relevant financial interests.

The Data Availability Statement (DAS): Data is “available on request”.

Ethical approval for research in volving human participants: The study was approved by the local ethics committee (Institutional Review Board approval no: KAEK/2022.01.18) at University of Health Sciences Basaksehir Cam and Sakura City Hospital. All procedures performed in our study involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards and this study was designed according to the STROCSS 2021 criteria.

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No competing interests reported.

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Effect of Preoperative Single-Dose Methylprednisolone Administration on Early Postoperative Pain Following Retrograde Intrarenal Surgery

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Introduction

Materials and Methods

Visual Analog Scale (VAS)

Statistical assessment of data

Results

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