Postoperative Pain After a Laparoscopic Cholecystectomy (CPOP)

November 11, 2024 updated by: Dr Amine BEN SAFTA, Hopital Charles Nicolle

Randomized Controlled Trial Comparing Low (8 MmHg) Vs. Standard (14 MmHg) CO2 Insufflation Pressure on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy

Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

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: Amine Ben Safta, Assistant hospitalo-universita
  • Phone Number: +216 29 693 979
  • Email: amine.bsa@gmail.com

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA 1 or ASA 2
  • uncomplicated symptomatic gallblader lithiasis scheduled for elective surgery
  • no choledocholithiasis
  • no associated surgical procedures
  • no cerebrovasculare accident with neurological sequelae or other neurological disorders that affects sensation of pain
  • no ascites
  • no carcinomatosis

Exclusion Criteria:

  • conversion to laparotomy
  • need to keep an escat drain

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pressure 8 mmHg
Procedure: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Active Comparator: Pressure 14 mmHg
Procedure: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: Hour 6
Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain
Hour 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morbidity
Time Frame: 30 days
30 days
postoperative length of stay
Time Frame: 30 days
30 days
postoperative pain
Time Frame: Hour 12
Visual Analog Scale (VAS) 0 no pain, 10 worst possible pain
Hour 12
Postoperative pain
Time Frame: Hour 24
Visual Analog Scale 0 no pain, 10 worst possible pain
Hour 24
vommiting (PONV score)
Time Frame: from 0 to 24 hours after surgery
Postoperative Nausea and vomiting (PONV) score 0 no PONV , 1 moderate nausea, 2 moderate vomiting, 3 uncontrollable nausea and/or vomiting
from 0 to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Charles Nicolle

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 (Estimated)

November 12, 2024

Primary Completion (Estimated)

November 2, 2025

Study Completion (Estimated)

December 2, 2025

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chir-BS-2024-01

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 Postoperative Pain

Clinical Trials on Laparoscopic cholecystectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe