Postoperative Pain After a Laparoscopic Cholecystectomy

NCT ID: NCT06685250

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2025-12-02

Brief Summary

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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

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pressure 8 mmHg

Group Type EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Pressure 14 mmHg

Group Type ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Interventions

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Laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Charles Nicolle

OTHER

Sponsor Role lead

Responsible Party

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Dr Amine BEN SAFTA

surgical fellow in General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amine Ben Safta, Assistant hospitalo-universita

Role: CONTACT

+216 29 693 979

Other Identifiers

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Chir-BS-2024-01

Identifier Type: -

Identifier Source: org_study_id

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