Clinical trial

Efficacy Methadone for Management Postoperative Pain After the Use of Anesthesia Intravenous in Laparoscopic Cholecystectomy

Name
P03/13
Description
The aim of this study is to compare the efficacy of methadone versus morphine in dealing with postoperative pain, in laparoscopic cholecystectomy under total intravenous anesthesia (TIVA); Efficacy is defined in terms of the difference of milligrams in morphine used as rescue analgesia postoperatively. Our hypothesis is that methadone is more effective than morphine for postoperative pain treatment.
Trial arms
Trial start
2013-03-01
Estimated PCD
2013-08-01
Trial end
2013-09-01
Status
Completed
Treatment
Morphine
Morphine group,receive morphine 0.08 mg / kg at the start of surgery
Arms:
Morphine
Methadone
Methadone group,receive methadone 0.08 mg / kg at the start of surgery
Arms:
Methadone
TIVA
TIVA: General anesthesia will be based on Remifentanil and Propofol (TIVA-TCI), titrated to achieve bispectral index (BIS) between 40 and 60.
Arms:
Methadone, Morphine
Size
86
Primary endpoint
Difference in milligrams of morphine used as rescue analgesia
First 24 hours postoperatively
Eligibility criteria
Inclusion Criteria: * Patients undergoing laparoscopic cholecystectomy in the Almirante Nef Naval Hospital * Patients ASA 1 or 2 Exclusion Criteria: * Patients with renal insufficiency (creatinine\> 2.0 mg / dl) * Patients with a history of liver failure * Patients with BMI\> 35 kg/m2 * Patients with hypersensitivity to the drugs in question * History of chronic use of opioids * Need for conversion to open surgery
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 86, 'type': 'ACTUAL'}}
Updated at
2023-09-26

1 organization

3 products

2 indications

Product
Morphine
Indication
Pain
Indication
Postoperative
Product
Methadone
Product
TIVA