Postoperative Pain After a Laparoscopic Cholecystectomy

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain

• Registration Number: NCT06685250
• Lead Sponsor: Hopital Charles Nicolle

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study Start: 2024-11-12
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-11-02
• Study Completion: 2025-12-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pain	Hour 6	Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain

Secondary Outcome Measures

Name	Time	Method
postoperative pain	Hour 12	Visual Analog Scale (VAS) 0 no pain, 10 worst possible pain
Postoperative pain	Hour 24	Visual Analog Scale 0 no pain, 10 worst possible pain
vommiting (PONV score)	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
morbidity	30 days
postoperative length of stay	30 days