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Not yet recruiting NCT06685250

Postoperative Pain After a Laparoscopic Cholecystectomy

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic cholecystectomy.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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

Interventions

  • Procedure Laparoscopic cholecystectomy
    Laparoscopic cholecystectomy

Primary outcome measures

  • Postoperative pain [Time frame: Hour 6]
Secondary outcome measures (5)
  • postoperative pain [Time frame: Hour 12]
  • Postoperative pain [Time frame: Hour 24]
  • vommiting (PONV score) [Time frame: from 0 to 24 hours after surgery]
  • morbidity [Time frame: 30 days]
  • postoperative length of stay [Time frame: 30 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 41411326

Identifiers

NCT: NCT06685250 · Chir-BS-2024-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗