Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06685250

Postoperative Pain After a Laparoscopic Cholecystectomy

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy

Primary outcomes

  1. 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

  1. postoperative pain

    Time frame: Hour 12

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

  2. Postoperative pain

    Time frame: Hour 24

    Visual Analog Scale 0 no pain, 10 worst possible pain

  3. vommiting (PONV score)

    Time frame: from 0 to 24 hours after surgery

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

  4. morbidity

    Time frame: 30 days

  5. postoperative length of stay

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Amine Ben Safta, Assistant hospitalo-universita

CONTACT

[email protected]

+216 29 693 979

Sponsors and collaborators

Lead sponsor

Hopital Charles Nicolle

Other

Registry information

Official study title

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

Acronym: CPOP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.