Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery

NCT05031234 | Completed

• 1 other identifier: 2020-A02585-34
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery

Conditions

Colectomy

Outcome Measures

Primary Outcomes (1)

• Morphine Use

  All intravenous and oral morphine consumed in the first 48 hours after surgery

  48 hours

Secondary Outcomes (26)

• Postoperative pain H12

  Hour 12

• Postoperative pain H24

  Hour 24

• Postoperative pain H36

  Hour 36

• Postoperative pain H48

  Hour 48

• Postoperative pain D30

  Day 30

Study Arms (2)

Group with morphine

ACTIVE COMPARATOR

conventional general anaesthesia with morphine

Drug: anaesthesia with morphine

Group without opiates

EXPERIMENTAL

general anaesthesia without opiates

Drug: anaesthesia without opiates

Interventions

anaesthesia without opiates DRUG

Anaesthesia without opiates for patients undergoing laparoscopic colectomy

Group without opiates

anaesthesia with morphine DRUG

anaesthesia with morphine for patients undergoing laparoscopic colectomy

Group with morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age who has read and signed the consent form for participation in the study
• Patient candidate for laparoscopic colectomy (planned or emergency) with possible conversion to laparotomy

You may not qualify if:

• Severe renal failure with baseline clearance\<30, hepatic failure with baseline PT\<40%, cardiac failure with LVEF\<20%.
• Patient under court protection, guardianship or curatorship
• Pregnant or breastfeeding patient
• Patient not affiliated to the French social security system
• Impossible to give the subject informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
• Contraindication to anaesthesia or to the administration of one of the products used in the anaesthesia protocol

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Médipôle

Villeurbanne, 69100, France

Location

Related Publications (1)

• Collange V, Berruet JB, Aubrun F, Poiblanc M, Olagne E, Golliet Mercier N, Parent S, Noel P, Devillez S, Perrou M, Ramadan J, Coeckelenbergh S, Joosten A. Opioid free versus opioid sparing strategies for multimodal antinociception during laparoscopic colectomy: a randomised controlled trial. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101436. doi: 10.1016/j.accpm.2024.101436. Epub 2024 Oct 9.

  PMID: 39393528 DERIVED

MeSH Terms

Interventions

Anesthesia; Opiate Alkaloids; Morphine

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Alkaloids; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient does not know which treatment is used for the anesthesia
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy. * Group 1: conventional general anaesthesia with morphine * Group 2: general anaesthesia without opiates

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: September 1, 2021
• Study Start: December 17, 2020
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)