Actively Recruiting

Phase 2
Phase 3
Age: 25Years - 65Years
All Genders
Healthy Volunteers
ID07590752

Comparison of Dexamethasone Versus Dexmedetomidine Added to 0.25% Bupivacaine in Ultrasound-Guided TAP Block for Postoperative Pain Relief in Laparotomy Patients

Led by Sahiwal medical college sahiwal · Updated on 2026-05-15

96

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of transversus abdominis plane (TAP) block with different adjuvants to improve pain relief after laparotomy surgery. This study compares the addition of dexamethasone or dexmedetomidine to bupivacaine in patients aged 25 to 65 years with ASA Class I or II status. The goal is to assess which combination provides longer-lasting postoperative analgesia and reduces the need for additional pain medication. Participants will be randomly assigned to one of two groups. Group A receives a TAP block with 18ml of 0.25% bupivacaine plus 2ml of dexamethasone (8mg). Group B receives the same bupivacaine dose plus 2ml of dexmedetomidine (1µg/kg diluted in saline). The TAP block is administered bilaterally under ultrasound guidance immediately after surgery, using a needle guided between the internal oblique and transversus abdominis muscles. Patients are monitored for complications like local anesthetic toxicity or hematoma. During the 24-hour postoperative period, patients' pain levels will be measured using a Visual Analogue Scale (VAS) at several time points. If pain is insufficiently controlled (VAS ≥4), rescue analgesia with IV ketorolac will be provided and the time to first rescue dose recorded. Additional assessments include monitoring nausea, vomiting, heart rate, and blood pressure. The primary outcome is the duration until the first request for rescue analgesia, with secondary outcomes focused on pain scores over 24 hours.

CONDITIONS

Brief Title

"Dexa vs Dexmedetomidine With Bupivacaine in TAP Block for Laparotomy Analgesia

Who Can Participate

Age: 25Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing laparotomy.
  • Patients aged 25 to 65 years.
  • Both genders.
  • Patients with ASA Class I or II.
Not Eligible

You will not qualify if you...

  • Patients who do not give consent.
  • Patients with comorbidities such as diabetes, hypertension, chronic kidney disease, or chronic liver disease.
  • Patients with bleeding disorders.
  • Infection at the site of injection.
  • Allergy to any drug, local anesthetic, or other drugs used in the study.
  • Patients with polytrauma.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single administration at surgery end

At the end of surgery, participants receive a bilateral Ultrasound-guided TAP block with either Bupivacaine plus Dexamethasone or Bupivacaine plus Dexmedetomidine for postoperative pain relief.

1 treatment visit (in-person)

Post-operative Follow-up

Duration - 24 hours

Participants are observed postoperatively with pain assessed using Visual Analogue Scale (VAS) scores at multiple time points and monitored for complications or need for rescue analgesia.

Visits at arrival to PACU and at 2, 4, 6, 12, and 24 hours post-operative

Trial Site Locations

Total: 1 location

1

Sahiwal Medical College

Sahiwal, Punjab Province, Pakistan, 57000

Actively Recruiting

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Research Team

D

Dr Maryam Mumtaz, MBBS

D

Dr Muhammad Shahid

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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