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NCT Number: NCT07285083

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

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.

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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Medical College

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location status: Recruiting

Location contact

RAMEESHA MUSHARAF, FCPS ANESTHESIA (PGR)

CONTACT

[email protected]

0092-334-5038000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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 (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

Primary outcomes

  1. Postoperative Pain Relief (Visual Analogue Scale - VAS)

    Time frame: Time Frame: 1-12 hours post-surgery.

    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.

Secondary outcomes

  1. Sedation Level (Ramsay Sedation Scale)

    Time frame: Time Frame: Up to 12 hours post-surgery.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rameesha Musharaf, FCPS ANESTHESIA (PGR)

CONTACT

[email protected]

0092-334-5038000

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Medical College

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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