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

Comparison Of Dexamethasone Versus Dexmedetomidine As An Adjuvant To 0.25% Bupivacaine In Ultrasound Guided Tap Block On Post-Op Analgesia Duration In Patients Undergoing Laparotomy

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Opioid Use; Laparotomy
• Intervention / Treatment: Drug: Bupivacaine Hcl 0.25% Inj_#1; Drug: Bupivacaine Hcl 0.25% Inj_#2

Detailed Description

After approval of synopsis by the research board and ethical committee and Research department CPSP Karachi, the data collection process will begin. The study will be conducted in the Anesthesia Department of Sahiwal Teaching Hospital Sahiwal. Written informed consent will be obtained from all the patients included in the study. Patients aged between 25 to 65 years, belonging to ASA class-I and class-II, scheduled for laparotomy will be divided into 2 groups of 48 patients each:

• 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).

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. Patients will be observed for any complication like signs of local anesthetic toxicity or hematoma formation at site of block. In PACU and surgical unit, Visual Analogue Scale Score (VAS) will be recorded at arrival to PACU 2, 4, 6, 12 and 24 hours post-operative. A VAS score of ≤3 will be considered satisfactory pain relief. If patients have inadequate analgesia, supplementary rescue analgesia will be given in the form of IV ketorolac 30mg at VAS ≥4. The time of first request for rescue analgesic will be recorded. Post-operative nausea and vomiting will be documented according to a categorical scale: 0 none, 1 nausea, 2 vomiting, 3 nausea and vomiting. Hemodynamic variables such as heart rate and mean arterial pressure will be recorded. The primary outcome will be to compare the time for first rescue analgesia. The secondary outcome will be assessment of postoperative pain using VAS score at 2, 6, 12, 18 and 24 hrs.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Dr Maryam Mumtaz, MBBS; Phone Number: 00923336238201; Email: Maryamsumra3@gmail.com
• Study Contact Backup: Name: Dr Muhammad Shahid; Phone Number: 00923336173056; Email: shahidnishtar@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Sahiwal, Punjab Province, Pakistan, 57000
      • Recruiting
      • Sahiwal Medical College
      • Contact: Dr Rao Riaz ul Haq, FCPS; Phone Number: 009240452470; Email: slmcswl@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GROUP A; GROUP BUPIVACAINE+DEXAMETHASONE	Drug: Bupivacaine Hcl 0.25% Inj_#1; 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.; Other Names: Bupivacaine+Dexamethasone
Other: GROUP B; GROUP BUPIVACAINE+DEXAMETHASONE+DEXMEDETOMIDINE	Drug: Bupivacaine Hcl 0.25% Inj_#2; 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.; Other Names: Bupivacaine+ Dexamethasone +Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	Duration of postop analgesia	24 hours

Collaborators and Investigators

• Sponsor: Sahiwal medical college sahiwal
• Investigators: Study Director: Adeel Riaz, MD, Sahiwal medical college sahiwal

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2024
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): July 4, 2026

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: 161/IRB/SLMC/SWL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available on request after completion of study i.e. July 2026
• IPD Sharing Time Frame: July 2026
• IPD Sharing Access Criteria: On Demand
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No