NCT07409688

Brief Summary

Laparoscopic cholecystectomy involves removal of gallbladder through small incision ports resulting in faster recovery. Small incisions are less painful and hence local anesthesis administered can be effective for pain management. This local anesthetic can be administered either within abdominal cavity or at sit of small incisions.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 17, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 19, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

Laparoscopic cholecystectomyPost Operative analgesiaLocal anesthetic administration

Outcome Measures

Primary Outcomes (2)

  • Post opestive pain score

    This will be measured using Visual Analog score upon arrival at post anesthesia care unit labelled as Time 0 then at time intervals 3h,6h, 12h and 24 hours post operatively

  • Rescue analgesia demand

    This will be the number of patients requiring resuce analgesia in 24h post operative period. Rescue analgesia will be administered if VAS score >4

Study Arms (2)

Intraperitoneal local anesthetic administration

EXPERIMENTAL
Drug: Intraoperitoneal local anesthetic administration

Sub cutaneous local anesthetic administration

ACTIVE COMPARATOR
Drug: Sub cutaneous administration of local anesthetic

Interventions

Intraperitoneal infiltration of 20ml of 0.25% Bupivacaine will be done at the end of procedure by the surgeon.

Intraperitoneal local anesthetic administration

port site infiltration of 20ml of 0.25% Bupivacaine will be done. 6ml for 10mm ports and 4ml for 5mm ports respectively.

Sub cutaneous local anesthetic administration

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA I and II

You may not qualify if:

  • Allergic to local anesthetic Open cholecystectomy History of chronic pain History of abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawalpindi Teaching Hospital, Rawalpindi

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Related Publications (1)

  • Bano N, Hayat N, Saleem S, Javaid F, Rehman A, Mudassir. Comparison of intraincisional and intraperitoneal infiltration of local anaesthetic in laparoscopic cholecystectomy to control early postoperative pain. Professional Med J 2021; 28(2):192-196. https://doi.org/10.29309/TPMJ/2021.28.02.6013

    BACKGROUND

Study Officials

  • Waqas Anjum

    Rawalpindi Medical College

    STUDY CHAIR

Central Study Contacts

Nimrah Iqbal Prinicpal Investigator, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 13, 2026

Study Start

January 17, 2026

Primary Completion

June 17, 2026

Study Completion

June 17, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Hospital ethical committee doesnt allow

Locations