- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409688
Pain Relief Following Laparoscopic Cholecystectomy While Comparing Intra Abdominal Versus Sub Cutaneous Local Anesthetic Administration
February 12, 2026 updated by: Nimrah Iqbal, Rawalpindi Medical College
Comparative Evaluation of Analgesic Outcomes of Intra-peritoneal Versus Subcutaneous Infiltration of Bupivacaine for Laparoscopic Cholecystectomy Patients "
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.
Study Overview
Status
Recruiting
Detailed Description
Laparoscopic cholecystectomy is a minimally invasive surgical procedure involving removal of the gallbladder through multiple small trocar incisions.
Compared with open surgery, this approach is associated with reduced postoperative pain, shorter hospital stay, and faster recovery.
Despite its minimally invasive nature, postoperative pain remains a significant concern, particularly at port sites and from intraperitoneal irritation.
Local anesthetic techniques have been shown to contribute to multimodal analgesia in laparoscopic surgery.
Local anesthetic agents may be administered either intraperitoneally or by infiltration at trocar insertion sites to reduce postoperative pain and opioid requirements.
However, the optimal route of local anesthetic administration for effective postoperative analgesia following laparoscopic cholecystectomy remains uncertain, warranting further clinical evaluation.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nimrah Iqbal Prinicpal Investigator, MBBS
- Phone Number: +92 335 0526611
- Email: drnimrahiqbal@gmail.com
Study Locations
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan
- Recruiting
- Rawalpindi Teaching Hospital, Rawalpindi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- ASA I and II
Exclusion Criteria:
- Allergic to local anesthetic Open cholecystectomy History of chronic pain History of abdominal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intraperitoneal local anesthetic administration
|
Intraperitoneal infiltration of 20ml of 0.25% Bupivacaine will be done at the end of procedure by the surgeon.
|
|
Active Comparator: Sub cutaneous 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post opestive pain score
Time Frame: 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
|
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
Time Frame: This will be the number of patients requiring resuce analgesia in 24h post operative period. Rescue analgesia will be administered if VAS score >4
|
This will be the number of patients requiring resuce analgesia in 24h post operative period. Rescue analgesia will be administered if VAS score >4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Waqas Anjum, Rawalpindi Medical College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2026
Primary Completion (Estimated)
June 17, 2026
Study Completion (Estimated)
June 17, 2026
Study Registration Dates
First Submitted
January 19, 2026
First Submitted That Met QC Criteria
February 12, 2026
First Posted (Actual)
February 13, 2026
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 12, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 4726/RTH/RWP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Hospital ethical committee doesnt allow
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Local Anesthetic Infiltration
-
Universidad Autonoma de San Luis PotosíCompletedPain Perception | Topical Anesthesia | Local Anesthetic InfiltrationMexico
-
Tanta UniversityRecruitingSpinal Anesthesia | General Anesthesia | Local Anesthetic Infiltration | Buccal Mucosal Graft | UrethroplastyEgypt
-
Tanta UniversityCompletedQuadratus Lumborum Block | Thoracolumbar Interfascial Plane Block | Local Anesthetic Infiltration | Lumbar Spine FixationEgypt
-
Mayo ClinicCompletedAnesthesia, Local | Photodamaged Skin | Topical and Infiltration Anesthetic ToxicityUnited States
-
University of AlexandriaRecruitingLocal InfiltrationEgypt
-
Konya Necmettin Erbakan ÜniversitesiCompleted
-
University of ZurichCompleted
-
The Cleveland ClinicCompleted
-
Sintetica SACross Research S.A.Completed
Clinical Trials on Intraoperitoneal local anesthetic administration
-
Sisli Hamidiye Etfal Training and Research HospitalNot yet recruitingPostoperative Pain | Cholecystitis | CholelithiasesTurkey (Türkiye)
-
Aretaieion University HospitalKAT General HospitalActive, not recruitingPain, Postoperative | Analgesia | Pain, Acute | Ketamine | Pain, Chronic | Morphine | Pain, NeuropathicGreece
-
Lithuanian University of Health SciencesUnknownPrimary Total Knee ArthroplastyLithuania
-
University of California, San DiegoEnrolling by invitationTrauma Injury | Pain, Acute PostoperativeUnited States
-
Istanbul UniversityCompleted
-
Royal Berkshire NHS Foundation TrustCompletedPain, PostoperativeUnited Kingdom
-
Ottawa Hospital Research InstituteUnknown
-
Hospital for Special Surgery, New YorkCompletedInterscalene Block | Shoulder ArthroscopyUnited States
-
Hôpital du ValaisUniversity of Lausanne HospitalsCompleted
-
Tanta UniversityCompletedQuadratus Lumborum Block | Thoracolumbar Interfascial Plane Block | Local Anesthetic Infiltration | Lumbar Spine FixationEgypt