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Clinical Trials/NCT07482709
NCT07482709RecruitingPhase 1

Transversus Abdominis Plane Block : A Comparative Study Between Bupivacaine vs Bupivacaine With Ketamine in Total Abdominal Hystrectomy

Liaquat National Hospital & Medical College1 site in 1 country30 target enrollmentStarted: November 1, 2025Last updated:
Interventions

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
VAS score

Study Overview

Brief Summary

The goal of this study is to know how effectively TAP block can reduce postoperative pain in total abdominal hystrectomy patients when given ketamine in addition to bupivacaine in TAP block and to compare it with the conventional TAP block with bupivacaine only. The main question it aims to answer is:

Does intervention with ketamine in TAP block lowers the postoperative pain measured via visual analog scale and decreases the need for rescue analgesia?

Patients will be assessed for pain in PACU( post anesthesia care unit), 6 hours, 12 hours and 24 hours postoperatively. Time of rescue analgesia will also be noted if given.

Detailed Description

This is a prospective, randomized, double blind control trial.Patients will be randomly divided into 2 groups; group A and group B with 15 patients in each group. Group A will recive TAP block with 20ml solution of 0.25% bupivacaine on each side of abdomen while group B will recieve 50mg ketamine in addtion to 20ml of 0.25% bupivacaine.The drugs will be prepared by the second anesthesiologist who will not be part of data collection and analysis.Post operative pain will be assessed using VAS score in PACU, after 6 , 12 and 24hours post total abdominal hystrectomy. Inj. tramadol 50mg will be used as rescue analgesia.In addition to inj. pracetamol 1g 8 hourly and inj. ketorolac 30mg 12 hourly, time for administration of rescue analgesia will be noted.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged between 25 to 60 years.
  • ASA grade I & II.
  • Undergoing total abdominal hysterectomy.

Exclusion Criteria

  • BMI >35kg/m
  • Patient refusal for participation.
  • Patients with coagulation disorders.
  • Patents with history of allergy and hypersensitivity to local anesthetic.
  • Patient having infection at the injection site.
  • Alcohol or drug abuse.
  • Cognitive or mental disorder.

Arms & Interventions

TAP block with bupivacaine only

Active Comparator

Intervention: bupivicaine 0.25% (Drug)

TAP block with bupivacaine plus ketamine

Experimental

Intervention: bupivicaine 0.25% + ketamine (Drug)

Outcomes

Primary Outcomes

VAS score

Time Frame: At PACU(5 mins after shifting to PACU), 6,12 and 24 hours post-operatively

VAS (visual analog scale ) score noted VAS of \<2 = no pain VAS of 2-4 = mild pain VAS of 5-6 = moderate pain VAS of \>6 = severe pain

Time of receiving first rescue analgesia

Time Frame: within first 24 hours postoperatively

time for additional requirment of inj. tramadol 50mg for post operative pain relief

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Usra Rahim

Principal Investigator

Liaquat National Hospital & Medical College

Study Sites (1)

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