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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-45
SponsorSheikh Zayed Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy.

Severe allergies to local anesthetics.

Pre-existing chronic pain conditions.

Participation in another clinical trial within the past 30 days.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Bupivacaine + Dexmedetomidine (TAP Block)Experimental treatment 1 intervention
Group B: Bupivacaine Only (TAP Block)Active comparator 1 intervention

Trial outcomes

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
Time Frame: 1-12 hours post-surgery.

Secondary outcomes

1

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
Time Frame: Up to 12 hours post-surgery.

Other outcomes

Sponsors and contacts

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