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

Comparison of Pain Relief by Bupivacaine With Dexmedetomidine and Bupivacaine Alone in Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries.

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Bupivacaine (TAP Block); Drug: Bupivacaine with Dexmedetomidine (TAP Block)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: RAMEESHA MUSHARAF, FCPS ANESTHESIA (PGR); Phone Number: 0092-334-5038000; Email: rameeshamusharaf96@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Rahim Yar Khan, Punjab Province, Pakistan, 64200
      • Recruiting
      • Sheikh Zayed Medical College
      • Contact: RAMEESHA MUSHARAF, FCPS ANESTHESIA (PGR); Phone Number: 0092-334-5038000; Email: rameeshamusharaf96@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine + Dexmedetomidine (TAP Block); 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	Drug: Bupivacaine (TAP Block); 10 ml of 0.25% bupivacaine administered bilaterally via ultrasound-guided transversus abdominis plane (TAP) block to provide postoperative analgesia for abdominal surgery
Active Comparator: Bupivacaine Only (TAP Block); 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	Drug: Bupivacaine with Dexmedetomidine (TAP Block); A combination of 0.25% bupivacaine and 1 mcg/kg dexmedetomidine administered bilaterally via ultrasound-guided transversus abdominis plane (TAP) block to provide postoperative analgesia for abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Relief (Visual Analogue Scale - VAS)	The primary outcome is postoperative pain level, measured using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable. Higher scores indicate worse pain. Pain scores will be recorded at 1, 3, 6, 9, and 12 hours post-surgery.	Time Frame: 1-12 hours post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation Level (Ramsay Sedation Scale)	Sedation level will be assessed using the Ramsay Sedation Scale, which ranges from 1 to 6, where 1 = anxious/agitated and 6 = no response to stimuli. Higher scores indicate deeper sedation. Measurements will be recorded at 15 minutes, 30 minutes, and 1, 3, 6, 9, and 12 hours post-surgery.	Time Frame: Up to 12 hours post-surgery.

Collaborators and Investigators

• Sponsor: Sheikh Zayed Medical College
• Investigators: Study Chair: Saira Sadaf, FCPS ANESTHESIA, Shaheed Ziaur Rahman Medical College

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Transversus abdominis plane (TAP) block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Chemically-Induced Disorders; Poisoning; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Bites and Stings; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine; Dexmedetomidine
• Other Study ID Numbers: 696/IRB/SZMC/SZH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study will not share individual participant data (IPD) due to the sensitive nature of the data and the lack of a formal data-sharing agreement. The study aims to protect patient confidentiality and privacy. As such, the data will only be used for the purpose of this trial and will not be made available to external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No