NCT07800624

Brief Summary

The study is about managing pain after laparoscopic gallbladder surgery. Pain after surgery is very common and can affect recovery, delay normal activities, and increase the length of hospital stay. Poorly controlled pain can also increase the risk of developing long-term pain. Good pain control can make patients more comfortable, reduce the need for opioid painkillers, shorten hospital stay, and improve patient satisfaction. Laparoscopic cholecystectomy is a common surgery for gallstones. Although it is done through small cuts, patients can still experience significant pain after the operation. This pain can come from the surgical wounds, the abdominal organs, and pain felt in other areas. A TAP block is a type of regional anesthesia that numbs the nerves supplying the abdominal wall. Previous studies have shown that TAP blocks may help reduce pain after surgery. However, there is limited research about its effectiveness in Pakistan and similar settings. Therefore, this study will compare patients who undergo laparoscopic cholecystectomy with a TAP block to those who undergo the surgery without a TAP block. The study will assess their pain levels, how much pain medication they need, and how long they stay in the hospital. The main aim is to determine whether using a TAP block can provide better pain control, reduce the need for painkillers, and shorten hospital stay after laparoscopic gallbladder surgery.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Aug 2026Nov 2026

First Submitted

Initial submission to the registry

August 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

August 30, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 23, 2026

Last Update Submit

August 30, 2026

Conditions

Keywords

TAP blockcholecystectomy, laparoscopicpost surgical pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain score

    Pain will be measured using the Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater postoperative pain (worse outcome).

    At 0 (recovery room), 6, 12, 24, and 48 hours after surgery.

Secondary Outcomes (1)

  • Length of hospital stay

    From the time of completion of surgery until hospital discharge, assessed continuously during the postoperative period up to 7 days after surgery or until discharge, whichever occurs first.

Study Arms (2)

Laparoscopic cholecystectomy with TAP Block

ACTIVE COMPARATOR

Patients in this group will undergo laparoscopic cholecystectomy with a Transversus Abdominis Plane (TAP) block. The TAP block will be given as a regional anesthesia technique to reduce postoperative abdominal pain. Their postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 0, 6, 12, 24, and 48 hours after surgery. Their analgesic requirements and length of hospital stay will also be recorded.

Procedure: TAP Block

Laparoscopic cholecystectomy without TAP Block

NO INTERVENTION

Patients in this group will undergo laparoscopic cholecystectomy without receiving a Transversus Abdominis Plane (TAP) block. They will receive the usual postoperative pain management provided as part of routine care. Their postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 0, 6, 12, 24, and 48 hours after surgery. Their analgesic requirements and length of hospital stay will also be recorded.

Interventions

TAP BlockPROCEDURE

The intervention will consist of a Transversus Abdominis Plane (TAP) block performed in patients undergoing laparoscopic cholecystectomy. The TAP block will involve the injection of a local anesthetic into the plane between the abdominal muscles to block sensory nerves supplying the abdominal wall. It will be used to reduce postoperative pain and decrease the need for additional analgesic medication. Its effectiveness will be assessed by comparing postoperative pain scores, analgesic requirements, and length of hospital stay with patients who do not receive a TAP block.

Also known as: Transverse abdominis plane block, Transversus abdominis plane block, Abdominal wall TAP Block
Laparoscopic cholecystectomy with TAP Block

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients diagnosed with symptomatic cholelithiasis and advised to undergo laparoscopic cholecystectomy.
  • Both Genders
  • Age more than 10 years and not above 60 years.

You may not qualify if:

  • Patients with contraindications for surgery.
  • Patients below the age of 10 years or above 60 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah postgraduate medical university

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (6)

  • Zako J, Kevorkov A, Jeffries SD, Ramirez-Garcia Luna JL, Daccache N, Song K, Harutyunyan R, Ritchie C, Cafferty O, Laferriere-Langlois P, Hemmerling TM. Transversus abdominis plane block for postoperative pain management and opioid sparing: a systematic review and meta-analysis of randomised controlled trials. Br J Anaesth. 2026 Jan;136(1):266-282. doi: 10.1016/j.bja.2025.10.033. Epub 2025 Dec 2.

    PMID: 41339171BACKGROUND
  • Atakan Ozkan, Nihat Gulaydin, Bahriye Kilic, Mert Mahsuni Sevinc. Is the application of subcostal transversus abdominis plane block effective for pain control in classical four-port laparoscopic aroscopic cholecystectomy?.Signa Vitae,2024,20(7):69-75 DOI:10.22514/sv.2024.076

    BACKGROUND
  • Wang W, Wang L, Gao Y. A Meta-Analysis of Randomized Controlled Trials Concerning the Efficacy of Transversus Abdominis Plane Block for Pain Control After Laparoscopic Cholecystectomy. Front Surg. 2021 Aug 4;8:700318. doi: 10.3389/fsurg.2021.700318. eCollection 2021.

    PMID: 34422893BACKGROUND
  • Osit LM, Gammad JJ, Flores OC (2021) The Efficacy of Ultrasound-Guided Bilateral Transversus Abdominal Plane (TAP) Block in Decreasing the Pain After Laparoscopic aroscopic Cholecystectomy : A Randomized Clinical Trial. J Med Res Surg 2(5): pp. 1-6. doi: 10.52916/jmrs214058

    BACKGROUND
  • Park S, Park JH, Park S, Jang JN, Kim C, Choi YS. Ultrasound-guided subcostal approach of transversus abdominis plane block compared with wound infiltration for postoperative analgesia following laparoscopic cholecystectomy: A systematic review and meta-analysis. Medicine (Baltimore). 2024 May 3;103(18):e38044. doi: 10.1097/MD.0000000000038044.

    PMID: 38701299BACKGROUND
  • Abraham S, Rivero HG, Erlikh IV, Griffith LF, Kondamudi VK. Surgical and nonsurgical management of gallstones. Am Fam Physician. 2014 May 15;89(10):795-802.

    PMID: 24866215BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Zarreen Raza, MBBS, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study participants will be divided into two groups using convenience sampling, with 100 patients in each group. Group A will include patients who will undergo laparoscopic cholecystectomy with a TAP block, while Group B will include patients who will undergo laparoscopic cholecystectomy without a TAP block. Postoperative pain will be assessed using the Visual Analogue Scale (VAS). Pain scores will be recorded at different time points, including immediately after surgery in the recovery room and at 6, 12, 24, and 48 hours postoperatively.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2026

First Posted

September 2, 2026

Study Start

August 30, 2026

Primary Completion

September 30, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations