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

NCT ID: NCT05031234

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2023-02-17

Brief Summary

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

Detailed Description

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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

Conditions

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Colectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The patient does not know which treatment is used for the anesthesia

Study Groups

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Group with morphine

conventional general anaesthesia with morphine

Group Type ACTIVE_COMPARATOR

anaesthesia with morphine

Intervention Type DRUG

anaesthesia with morphine for patients undergoing laparoscopic colectomy

Group without opiates

general anaesthesia without opiates

Group Type EXPERIMENTAL

anaesthesia without opiates

Intervention Type DRUG

Anaesthesia without opiates for patients undergoing laparoscopic colectomy

Interventions

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anaesthesia without opiates

Anaesthesia without opiates for patients undergoing laparoscopic colectomy

Intervention Type DRUG

anaesthesia with morphine

anaesthesia with morphine for patients undergoing laparoscopic colectomy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Patient participating in another interventional research or in a period of exclusion from a previous research
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé Médipôle

Villeurbanne, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 39393528 (View on PubMed)

Other Identifiers

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2020-A02585-34

Identifier Type: -

Identifier Source: org_study_id