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Clinical trial

Randomized Control Study on the Effectiveness of Intraoperative Methadone on Postoperative Pain Control

ID
Name
2022-14040
Description
To compare patient pain perception and satisfaction as well as opioid-related side effects during inpatient and outpatient care when undergoing bariatric enhanced recovery after surgery protocols with and without methadone.
Trial arms
Trial start
2023-09-01
Estimated PCD
2024-02-01
Trial end
2024-02-01
Status
Withdrawn
Phase
Early phase I
Treatment
Methadone
One group will receive 10mg of methadone upon induction, while the other will receive a saline solution as placebo. We will see the effectiveness of methadone on postoperative pain management, while monitoring for opioid-related side effects.
Arms:
Methadone group
Primary endpoint
Postoperative opioid use
24 hours postoperatively
Eligibility criteria
Inclusion Criteria: • All patients undergoing initial gastric sleeve resection Exclusion Criteria: * Age \<18 years or \>60 years * Patients with BMI \>60 * AHI \> 30 (AHI = Apnea-Hypopnea Index), indicative of severe Obstructive Sleep Apnea (OSA) * ASA IV or V (American Society of Anesthesiology physical status classification system) * Patients taking opioids for chronic conditions in the last 10 days preceding the surgery * Patients currently being treated for chronic opioid addiction * Patients with severe psychiatric diagnoses * Allergies to medications used in protocol
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-10-18

1 organization

1 product

1 indication

Organization
Montefiore Medical Center
Product
Methadone
Indication
Bariatric Surgery Candidate