Bupivacaine With or Without Dexmedetomidine for Postoperative Pain Relief in Abdominal Surgery

Sheikh Zayed Medical College

Status: Enrolling

Conditions: Pain, Postoperative

Treatments: Drug: Bupivacaine (TAP Block); Drug: Bupivacaine with Dexmedetomidine (TAP Block)

Study type: Interventional

Funder types: Other

Identifiers

NCT07285083

696/IRB/SZMC/SZH

Details and patient eligibility

About

This study investigates the effectiveness of adding dexmedetomidine to bupivacaine for postoperative analgesia in patients undergoing abdominal surgeries. The research compares pain relief in two groups: one receiving a combination of bupivacaine and dexmedetomidine via a transversus abdominis plane (TAP) block, and the other receiving bupivacaine alone. The study aims to evaluate whether dexmedetomidine enhances pain relief, reduces the need for additional pain medication, and impacts sedation and side effects such as hypotension, bradycardia, and nausea. Conducted at Sheikh Zayed Medical College in Rahim Yar Khan, Pakistan, the trial will involve 80 participants and will measure pain using the Visual Analogue Scale (VAS), along with monitoring other vital parameters and complications over 12 hours post-surgery. The primary objective is to determine if the addition of dexmedetomidine provides superior pain control without significantly increasing side effects.

Full description

This randomized controlled trial will assess the comparative effectiveness of bupivacaine with and without dexmedetomidine in managing postoperative pain following abdominal surgeries. The study will be conducted at Sheikh Zayed Medical College and Hospital, Rahim Yar Khan, Pakistan. A total of 80 patients, aged 21-45 years, undergoing elective abdominal surgeries will be included. These participants will be randomly divided into two groups: Group A will receive a combination of bupivacaine and dexmedetomidine, and Group B will receive only bupivacaine.

The primary outcome is pain relief, assessed using the Visual Analogue Scale (VAS) at multiple time points. Secondary outcomes include the Ramsay Sedation Score, heart rate, mean arterial pressure, and the occurrence of side effects such as hypotension, bradycardia, and nausea. Rescue analgesia will be provided if the VAS score exceeds 4. Both groups will receive ultrasound-guided TAP blocks at the end of their surgeries.

The study aims to evaluate whether the addition of dexmedetomidine improves the duration of analgesia and reduces the need for additional analgesics without exacerbating side effects. The null hypothesis is that there will be no significant difference in pain relief between the two groups, while the alternative hypothesis is that dexmedetomidine will provide superior analgesia.

Statistical analysis will be performed using SPSS v23, with a significance level set at p < 0.05. Data will be analyzed for both quantitative outcomes (e.g., pain scores, heart rate, blood pressure) and qualitative outcomes (e.g., side effects). Stratification by age, gender, and comorbidities will control for potential confounding variables.

Enrollment: 80 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 21 to 45 years.
2. Undergoing elective abdominal surgery (exploratory laparotomy, ileostomy reversal, laparoscopic/open cholecystectomy, mesh repair of paraumbilical hernias).
3. The patient must be capable of providing informed consent.

Exclusion criteria

1. Pregnancy.
2. Severe allergies to local anesthetics.
3. Pre-existing chronic pain conditions.
4. Participation in another clinical trial within the past 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Bupivacaine + Dexmedetomidine (TAP Block)

Experimental group

Description:

Participants in this arm will receive a combination of 20 ml of 0.25% bupivacaine and 1 mcg/kg dexmedetomidine administered via an ultrasound-guided transversus abdominis plane (TAP) block for postoperative pain management following abdominal surgery

Treatment:

Drug: Bupivacaine (TAP Block)

Bupivacaine Only (TAP Block)

Active Comparator group

Description:

Participants in this arm will receive 20 ml of 0.25% bupivacaine administered via an ultrasound-guided transversus abdominis plane (TAP) block for postoperative pain management following abdominal surgery

Treatment:

Drug: Bupivacaine with Dexmedetomidine (TAP Block)