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

NCT07590752 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 161/IRB/SLMC/SWL
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Transversus abdominis plane block is a regional anesthetic technique which blocks the abdominal neural afferents by introducing local anesthetic into the neuro-fascial plane between the internal oblique and the transversus abdominis muscle and gives analgesia from the skin to parietal peritoneum. There are studies showing evidence of improved post operative analgesia with addition of adjuvants such as dexmedetomidine or dexamethasone in comparison with plane local anesthesia in terms of time to rescue analgesia and the overall quantity of analgesic used post operatively.

Conditions

Opioid Use; Laparotomy; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  Duration of postop analgesia

  24 hours

Study Arms (2)

GROUP A

OTHER

GROUP BUPIVACAINE+DEXAMETHASONE

Drug: Bupivacaine Hcl 0.25% Inj_#1

GROUP B

OTHER

GROUP BUPIVACAINE+DEXAMETHASONE+DEXMEDETOMIDINE

Drug: Bupivacaine Hcl 0.25% Inj_#2

Interventions

Bupivacaine Hcl 0.25% Inj_#1 DRUG

At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed using ultrasound machine. The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line. The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles. Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation.

Also known as: Bupivacaine+Dexamethasone

GROUP A

Bupivacaine Hcl 0.25% Inj_#2 DRUG

At the end of the surgery, bilateral Ultrasound (U/S) guided TAP block will be performed in both groups using ultrasound machine. The patient will be in supine position and a high frequency linear probe will be placed transverse to abdominal wall between the costal margin and iliac crest at mid axillary line. The needle will be introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transverse abdominis muscles. Upon reaching the plane and after negative aspiration test for blood, 2ml of saline will be injected to confirm correct needle position, after which the patient will receive the TAP block as per the group allocation.

Also known as: Bupivacaine+ Dexamethasone +Dexmedetomidine

GROUP B

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing laparotomy.
• Patients aged 25 to 65 years.
• Both genders.
• Patients with ASA Class I, II.

You may not qualify if:

• Patients who do not give consent.
• Patients with Comorbidities like DM, HTN, CKD, CLD.
• Patients with bleeding disorders.
• Infection at site of injection.
• Allergy to any drug, local anaesthetic, or other drugs used.
• Patients with polytrauma.

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead

Study Sites (1)

Sahiwal Medical College

Sahiwal, Punjab Province, 57000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Adeel Riaz, MD

  Sahiwal medical college sahiwal

  STUDY DIRECTOR

Central Study Contacts

Dr Maryam Mumtaz, MBBS

CONTACT

00923336238201; Maryamsumra3@gmail.com

Dr Muhammad Shahid

CONTACT

00923336173056; shahidnishtar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Anesthetist

Model Details: * Group A: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2 ml Dexamethasone 8mg. * Group B: Patients who will receive transversus abdominis plane block with - 18ml Bupivacaine 0.25%+ 2ml Dexmedetomidine (1µg/Kg diluted in 2ml saline).

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 15, 2026
• Study Start: March 3, 2024
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): July 4, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: July 2026
• Access Criteria: On Demand

Locations

PA (1)