Postoperative Pain After a Laparoscopic Cholecystectomy
CPOP
Randomized Controlled Trial Comparing Low (8 MmHg) Vs. Standard (14 MmHg) CO2 Insufflation Pressure on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy
1 other identifier
interventional
190
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Nov 2024
Typical duration for not_applicable postoperative-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
November 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2025
CompletedNovember 12, 2024
November 1, 2024
12 months
November 8, 2024
November 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain
Hour 6
Secondary Outcomes (5)
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
Study Arms (2)
Pressure 8 mmHg
EXPERIMENTALPressure 14 mmHg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- conversion to laparotomy
- need to keep an escat drain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ben Safta A, Nasri S, Samaali I, Taher H, Trabelsi MM, Dziri C, Dougaz W, Nouira R. Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol. PLoS One. 2025 Dec 18;20(12):e0339161. doi: 10.1371/journal.pone.0339161. eCollection 2025.
PMID: 41411326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- surgical fellow in General Surgery
Study Record Dates
First Submitted
November 8, 2024
First Posted
November 12, 2024
Study Start
November 12, 2024
Primary Completion
November 2, 2025
Study Completion
December 2, 2025
Last Updated
November 12, 2024
Record last verified: 2024-11