Intraoperative Methadone for Postoperative Pain Control

Montefiore Medicine Academic Health System

Status and phase: Withdrawn; Phase 4

Conditions: Bariatric Surgery Candidate

Treatments: Drug: Methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT05845359

2022-14040

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Methadone group

Experimental group

Description:

Patients in this group will receive intraoperative methadone.

Treatment:

Drug: Methadone

Control group

No Intervention group

Description:

Patients in this group will receive saline (placebo), instead of methadone