Clinical trial
Evaluation of the Benefit of Non-opioid General Anaesthesia on Postoperative Pain in Laparoscopic Colonic Surgery
Name
2020-A02585-34
Description
Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery
Trial arms
Trial start
2020-12-17
Estimated PCD
2023-02-17
Trial end
2023-02-17
Status
Completed
Treatment
anaesthesia without opiates
Anaesthesia without opiates for patients undergoing laparoscopic colectomy
Arms:
Group without opiates
anaesthesia with morphine
anaesthesia with morphine for patients undergoing laparoscopic colectomy
Arms:
Group with morphine
Size
160
Primary endpoint
Morphine Use
48 hours
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.\n\n* Group 1: conventional general anaesthesia with morphine\n* Group 2: general anaesthesia without opiates', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The patient does not know which treatment is used for the anesthesia', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 160, 'type': 'ACTUAL'}}
Updated at
2023-12-18
1 organization
2 products
1 indication
Product
Anaesthesia without opiatesIndication
ColectomyProduct
Anaesthesia with Morphine