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Clinical Trials/NCT06685250
NCT06685250
Not yet recruiting
Not Applicable

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

Hopital Charles Nicolle0 sites190 target enrollmentNovember 12, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Hopital Charles Nicolle
Enrollment
190
Primary Endpoint
Postoperative pain
Status
Not yet recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
November 12, 2024
End Date
December 2, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Amine BEN SAFTA

surgical fellow in General Surgery

Hopital Charles Nicolle

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: Hour 6

Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain

Secondary Outcomes

  • postoperative pain(Hour 12)
  • Postoperative pain(Hour 24)
  • vommiting (PONV score)(from 0 to 24 hours after surgery)
  • morbidity(30 days)
  • postoperative length of stay(30 days)

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