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

NCT07285083 | Recruiting DMC

• 1 other identifier: 696/IRB/SZMC/SZH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

Transversus abdominis plane (TAP) block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sedation Level (Ramsay Sedation Scale)

  Time Frame: Up to 12 hours post-surgery.

Study Arms (2)

Bupivacaine + Dexmedetomidine (TAP Block)

EXPERIMENTAL

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)

Bupivacaine Only (TAP Block)

ACTIVE COMPARATOR

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)

Interventions

Bupivacaine with Dexmedetomidine (TAP Block) DRUG

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

Bupivacaine Only (TAP Block)

Bupivacaine (TAP Block) DRUG

10 ml of 0.25% bupivacaine administered bilaterally via ultrasound-guided transversus abdominis plane (TAP) block to provide postoperative analgesia for abdominal surgery

Bupivacaine + Dexmedetomidine (TAP Block)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh Zayed Medical College

Rahim Yar Khan, Punjab Province, 64200, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Saira Sadaf, FCPS ANESTHESIA

  Shaheed Ziaur Rahman Medical College

  STUDY CHAIR

Central Study Contacts

Rameesha Musharaf, FCPS ANESTHESIA (PGR)

CONTACT

0092-334-5038000; rameeshamusharaf96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This study will use a double-blind design, where both the participants and care providers (including anesthesiologists) are unaware of the treatment allocation. The outcomes assessors are also blinded to ensure unbiased pain assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: POST GRADUATE RESIDENT (ANESTHESIA)

Model Details: This is a randomized controlled trial (RCT) where patients are assigned to one of two groups. Group A will receive bupivacaine with dexmedetomidine, and Group B will receive only bupivacaine via a transversus abdominis plane (TAP) block. The primary outcome is pain relief measured by the Visual Analogue Scale (VAS).

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 16, 2025
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)