Postoperative Pain After a Laparoscopic Cholecystectomy (CPOP)

Hopital Charles Nicolle

Status: Not yet enrolling

Conditions: Postoperative Pain

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06685250

Chir-BS-2024-01

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups

Pressure 8 mmHg

Experimental group

Treatment:

Procedure: Laparoscopic cholecystectomy

Pressure 14 mmHg

Active Comparator group

Treatment:

Procedure: Laparoscopic cholecystectomy