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

Not Applicable

Completed

• Conditions: Colectomy
• Interventions: Drug: anaesthesia with morphine; Drug: anaesthesia without opiates

• Registration Number: NCT05031234
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-01
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with morphine	anaesthesia with morphine	conventional general anaesthesia with morphine
Group without opiates	anaesthesia without opiates	general anaesthesia without opiates

Primary Outcome Measures

Name	Time	Method
Morphine Use	48 hours	All intravenous and oral morphine consumed in the first 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Duration of Mean arterial pressure <65	48 hours	Duration of Mean arterial pressure \<65 mmHg (min)
Postoperative pain H12	Hour 12	Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Duration of Mean arterial pressure <55	48 hours	Duration of Mean arterial pressure \<65 mmHg (min)
Average heart rate	48 hours	Average heart rate
Postoperative pain H24	Hour 24	Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Postoperative pain H36	Hour 36	Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Postoperative pain H48	Hour 48	Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Postoperative pain D30	Day 30	Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
Atropine dose administered	48 hours	Atropine dose administered (mg)
Mean arterial pressure	48 hours	Mean arterial pressure (MAP) (mmHg)
Mean arterial pressure variability	48 hours	MAP variability in percentage
Heart rate variability	48 hours	Heart rate variability in percentage
Bradycardia duration < 50	48 hours	Bradycardia duration \< 50 (min)
Ephedrine dose administered	48 hours	Ephedrine dose administered (mg)
Noradrenaline dose administered	48 hours	Noradrenaline dose administered (ug)
Neosynephrine dose administered	48 hours	Neosynephrine dose administered (ug)
Urapidil dose	48 hours	Urapidil dose (mg)
Nicardipine dose	48 hours	Nicardipine dose (mg)
Postoperative hypoxemia	48 hours	Postoperative hypoxemia (Yes/No)
Consumption of non-morphine drug	Day 90	Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics
Assessment of tolerance	Day 90	All adverse events will be collected and compared between the 2 groups
Assessment of disability	Day 90	Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0). Evolution between Day 30 and Day 90.
Time to extubation, time to resumption of transit, time to onset of first gas, length of stay in ICU and total length of hospital stay	Day 90 at least	Time to extubation, time to resumption of transit, time to onset of first gas, length of stay in ICU and total length of hospital stay
Immediate postoperative hypoxemia	Day 1	Immediate postoperative hypoxemia
Oxygen requirement	Day 2	Oxygen requirement (yes/no at D0, D1, D2)

Trial Locations

Locations (1)

Hôpital Privé Médipôle; 🇫🇷 Villeurbanne, France