NCT07465406

Brief Summary

This study compares the effectiveness of a Transversus Abdominis Plane (TAP) block in reducing post-operative pain for patients undergoing laparoscopic cholecystectomy. Sixty patients were divided into two groups: one group received a TAP block with a local anesthetic at the end of surgery, and the control group did not. The main goal was to see if the TAP block significantly lowers pain scores (measured on a scale of 0 to 10) within the first 12 hours after surgery and if it reduces the need for additional pain-relief medications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 7, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Laparoscopic CholecystectomyTAP BlockPost Operative PainGallbladderPost Operative Opioid ConsumptionVisual Analog ScaleERAS

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) Score for Pain

    A subjective psychometric response scale used to measure pain intensity. It consists of a 10 cm line where 0 represents "no pain" and 10 represents "the worst pain imaginable.".

    12 hours post-operation

Secondary Outcomes (1)

  • Time for First Request of Rescue Analgesia

    Within the first 24 hours post-operation.

Study Arms (2)

TAP Block Group

EXPERIMENTAL

Patients in this group received a Transversus Abdominis Plane (TAP) block at the end of the laparoscopic cholecystectomy but before extubation.

Drug: Bupivacaine 0.25%

Control Group (The No TAP Block Group)

OTHER

Patients in this group underwent laparoscopic cholecystectomy under the same general anesthesia protocol but did not receive a TAP block

Other: Standard Post-Operative Care

Interventions

Transversus Abdominis Plane (TAP) block administered by injecting 20ml of 0.25% Bupivacaine between the internal oblique and transversus abdominis muscles.

TAP Block Group

Patients received the routine post-operative analgesia protocol of the hospital (e.g., IV Ketorolac or Paracetamol) without the administration of a TAP block

Control Group (The No TAP Block Group)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years
  • Both genders
  • Patients diagnosed with Cholelithiasis in accordance with operational definition and planned to undergo Laparoscopic Cholecystectomy

You may not qualify if:

  • Patients with ASA of ≥ 3
  • Patients diagnosed with acute cholecystitis, empyema, mucocele or perforated gall bladder
  • Patients planned to undergo laparoscopic cholecystectomy alongside other abdominal procedures
  • Patients with body mass index of ≥ 35 Kg/m2
  • Patients with history of coagulation disorders like hemophilia or those with history of anti-platelet drugs use in last 2 weeks
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darul Sehat Hospital- Liaquat College of Medicine & Dentistry.

Karachi, Pakistan

Location

MeSH Terms

Conditions

CholelithiasisPain, Postoperative

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Resident -FCPS Trainee

Study Record Dates

First Submitted

March 7, 2026

First Posted

March 11, 2026

Study Start

March 11, 2025

Primary Completion

August 11, 2025

Study Completion

August 11, 2025

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data at this time

Locations