Postoperative Pain After a Laparoscopic Cholecystectomy

N/ANot Yet RecruitingNCT06685250

Hopital Charles Nicolle190 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

190

Conditions

Postoperative Pain

Interventions

Laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: Hour 6

Secondary Outcomes

postoperative pain

Visual Analog Scale (VAS) 0 no pain, 10 worst possible pain

Time frame: Hour 12

Postoperative pain

Visual Analog Scale 0 no pain, 10 worst possible pain

Time frame: Hour 24

vommiting (PONV score)

Postoperative Nausea and vomiting (PONV) score 0 no PONV , 1 moderate nausea, 2 moderate vomiting, 3 uncontrollable nausea and/or vomiting

Time frame: from 0 to 24 hours after surgery

morbidity

Time frame: 30 days

postoperative length of stay

Time frame: 30 days

Central Contacts

Amine Ben Safta, Assistant hospitalo-universita

CONTACT

+216 29 693 979 amine.bsa@gmail.com

Data from ClinicalTrials.gov

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