Effects Of Two Different Doses Of Pre-Emptive Oral Tapentadol for Attenuation Of Catheter Related Bladder Discomfort In Patient Undergoing Elective Surgeries under General Anaesthesia: A Double Blind Randomised Clinical Trial

INTRODUCTION

Urinary bladder catheterization is a common practice in various urological surgeries. It can lead to catheter related bladder discomfort (CRBD) which is defined as a feeling of urgency to urinate, a sensation of burning and discomfort in suprapubic region postoperatively.

CRBD is a common cause of post-operative distress, pain and can increase the risk for emergence agitation in early post-operative period in all surgeries with foley’s catheter in situ, mainly in urological interventions.

CRBD resembles an overactive bladder. It involves involuntary contraction of bladder which is mediated by muscarinic receptors and is the main cause of CRBD. The agents with anti-muscarinic activity such as oxybutinin, butyl scopolamine and tolterodine form the first line of treatment. Drugs modulating pain pathway like tramadol, tapentadol, parecoxib, gabapentin, and pregabalin have also been found effective in the management of CRBD.           Tapentadol is a novel opioid analgesic that acts centrally to attenuate pain. Previous studies have shown that tapentadol has dual mechanisms of action as a mu-opioid receptor agonist and noradrenaline re-uptake inhibition. Therefore, tapentadol provides a great advantage over classic opioids in pain management from nociceptive to neuropathic, Cumulative evidence from in vitro data suggests that tapentadol effect on norepinephrine re-uptake could be a new target that overcomes other classic opioids in chronic neuropathic pain.     Compared to other opioids tapantadol has fewer side effects. Tapentadol is a new alternative to treat acute, chronic, and neuropathic pain.      Along with CRBD, surgical stress response also encompasses a cascade of physiological changes, including inflammatory and hormonal responses, triggered by surgical trauma, potentially influencing the patient’s recovery trajectory. The stress that is caused during a surgical procedure causes disturbance in metabolic and physiologic levels of cortisol.       Recognizing the importance of effective management for both CRBD and the surgical stress response, this study aims to evaluate the efficacy of two different doses of tapentadol, an analgesic.

By investigating the impact of tapentadol on CRBD and the surgical stress response, we aim to contribute valuable insights that could enhance perioperative care strategies, improve patient outcomes, and refine our understanding of the pharmacological management of postoperative discomfort.

   AIM OF STUDY

 To compare the efficacy of two different doses of tapentadol, for attenuation of catheter related bladder discomfort in patients undergoing elective surgeries.

OBJECTIVES OF STUDY

PRIMARY OBJECTIVES

To compare the efficacy of two different doses of tapentadol for attenuation of catheter related bladder discomfort.

 SECONDARY OBJECTIVES

1.     To compare surgical stress response.

2.     To study hemodynamic variable of patient.

postoperative nausea and vomiting.              

INCLUSION CRITERIA

Patients between the ages of 18-60 years of either sex.

Body mass index between 18.5 to 29.9kg/m2

ASA grade I and II

Posted for elective surgery under General Anaesthesia requiring urinary catheterization for > 24 hrs.

 EXCLUSION CRITERIA

Patient refusal

Known allergy to the drug

Opioid tolerance/dependence

Renal/hepatic impairment

Known respiratory impairment like asthma

Patient with any neurological disorder

Intestinal obstruction

Pregnant woman and breastfeeding woman

Failure to catheterize in a single attempt

Patient with previous history of urethral surgery or known case of uretheral pathology.

METHODOLOGY

This prospective, randomized, clinical trial aims to compare the efficacy of two different doses of tapentadol (50 mg and 75 mg) in managing catheter-related bladder discomfort (CRBD) and mitigating surgical stress responses in patients undergoing surgical procedures.The study will adhere to ethical standards after obtaining approval from the Institutional Review Board and Informed Written consent from patient.        Patients scheduled for elective surgeries, in which urinary catheterization is supposed to be maintained for more than 24 hours post-surgery will be recruited based on the inclusion criteria and randomly assigned to one of the two groups: Group A and Group B.        Group A(n=50) will receive oral tapentadol 75 mg and group B(n=50) will receive oral tapentadol 50 mg. Blinding will be ensured by using identical-looking medication packages.

On the day of surgery, preoperative baseline assessments, including vital signs such as heart rate, systolic blood pressure, diastolic blood pressure, and SpO2 will be recorded. Eligible participants will receive their assigned medication, orally with sips of water, 1 hour before the induction of anesthesia.

The included patients will be catheterized with Foley’s catheter after application of adequate amount of water-soluble jelly for lubrication to avoid any uretheral trauma. The balloon will we inflated for 10 ml Normal Saline.

Postoperatively, patients will be monitored for CRBD. The severity of CRBD will be evaluated by a blinded assessor at intervals of 0 hour., 0.5 hour, 1, 2, 3, 4, 5, 6, 24 hour post-operatively, Grade 1 – no pain, Grade 2 – mild pain (revealed by asking the patient), Grade 3- moderate pain (spontaneous complaint by patient), Grade 4- severe discomfort (agitation, loud complaints and attempt to remove catheter.       Hemodynamic variables such as heart rate, systolic blood pressure, diastolic blood pressure, and SpO2 will be recorded at 0-hour, 0.5 hour, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, and 6hrs and over 24 hours post-surgery

Sample for serum cortisol level will be sent 2 hours before surgery and 2 hours after completion of surgery.

Postoperative pain will be assessed by the visual analog scale (VAS) score, which varied from 0 to 10, where 0 indicated no pain and 10 the worst imaginable pain. Data will be collected at 0-hour, 0.5 hour, 1hour, 2hour, 3hour, 4hour, 5hour, and 6hours and over 24 hours post-surgery.

Postoperative nausea and vomiting will be assessed as a score of 0,1 or 2 (0= no nausea or vomiting, 1= tolerable nausea and vomiting and 2= intractable nausea and vomiting).

  Statistical Analysis - It will be done using Microsoft Excel and SSPS version 29 IBM Inc.

Data Analysis - The quantitative data (height, weight, duration of surgery, hemodynamic parameters, SpO2, VAS score and serum cortisol levels) will be expressed in the terms of mean and standard deviation while qualitative data (age, ASA physical status, sedation score, CRBD score, other complaints) will be expressed in terms of frequency and percentage. The means of the continuous variables will be compared among the two groups using analysis of variance (ANOVA). Hemodynamic changes will be compared with the help of t-test statistics. A P<0.05 will be considered statistically significant.