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

Study Overview
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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

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

Conditions
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Colectomy

Intervention / Treatment
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* Drug: anaesthesia without opiates
* Drug: anaesthesia with morphine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group with morphine<br>conventional general anaesthesia with morphine | Drug: anaesthesia with morphine<br>* anaesthesia with morphine for patients undergoing laparoscopic colectomy<br>|
| Experimental: Group without opiates<br>general anaesthesia without opiates | Drug: anaesthesia without opiates<br>* Anaesthesia without opiates for patients undergoing laparoscopic colectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Use | All intravenous and oral morphine consumed in the first 48 hours after surgery | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| Immediate postoperative hypoxemia | Immediate postoperative hypoxemia | Day 1 | 
| Oxygen requirement | Oxygen requirement (yes/no at D0, D1, D2) | Day 2 | 
| Neosynephrine dose administered | Neosynephrine dose administered (ug) | 48 hours | 
| Urapidil dose | Urapidil dose (mg) | 48 hours | 
| Nicardipine dose | Nicardipine dose (mg) | 48 hours | 
| Postoperative hypoxemia | Postoperative hypoxemia (Yes/No) | 48 hours | 
| Consumption of non-morphine drug | Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics | Day 90 | 
| Assessment of tolerance | All adverse events will be collected and compared between the 2 groups | Day 90 | 
| Assessment of disability | Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0) | Day 30 | 
| Assessment of disability | Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0). Evolution between Day 30 and Day 90. | Day 90 | 
| Postoperative pain H12 | 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. | Hour 12 | 
| Postoperative pain H24 | 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. | Hour 24 | 
| Postoperative pain H36 | 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. | Hour 36 | 
| Postoperative pain H48 | 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. | Hour 48 | 
| Postoperative pain D30 | 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. | Day 30 | 
| Mean arterial pressure | Mean arterial pressure (MAP) (mmHg) | 48 hours | 
| Mean arterial pressure variability | MAP variability in percentage | 48 hours | 
| Duration of Mean arterial pressure <65 | Duration of Mean arterial pressure <65 mmHg (min) | 48 hours | 
| Duration of Mean arterial pressure <55 | Duration of Mean arterial pressure <65 mmHg (min) | 48 hours | 
| Average heart rate | Average heart rate | 48 hours | 
| Heart rate variability | Heart rate variability in percentage | 48 hours | 
| Bradycardia duration < 50 | Bradycardia duration < 50 (min) | 48 hours | 
| Atropine dose administered | Atropine dose administered (mg) | 48 hours | 
| Ephedrine dose administered | Ephedrine dose administered (mg) | 48 hours | 
| Noradrenaline dose administered | Noradrenaline dose administered (ug) | 48 hours |