Intraoperative Methadone for Postoperative Pain Control

NCT05845359 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2022-14040
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bariatric Surgery Candidate

Keywords

methadone; bariatric surgery; pain management

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid use

  Postoperative opioid use will be determined by the amount of morphine consumed (milligram morphine equivalents, MME) at 24 hours postoperatively

  24 hours postoperatively

Secondary Outcomes (12)

• Total Postoperative opioid use

  48 hours postoperatively and approximately at 2 weeks (follow up visit upon discharge)

• Respiratory interventions

  Up to 4 hours postoperatively

• Duration of hospital stay

  Approximately 5 days postoperatively

• Patients Perception of Pain Management

  24 hours postoperatively

• Patients Perception of Pain Management

  2 days postoperatively

Study Arms (2)

Methadone group

EXPERIMENTAL

Patients in this group will receive intraoperative methadone.

Drug: Methadone

Control group

NO INTERVENTION

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

Interventions

Methadone DRUG

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.

Methadone group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients undergoing initial gastric sleeve resection

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Conditions

Agnosia

Interventions

Methadone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Jennifer Choi, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: May 6, 2023
• Study Start: September 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share