Intraoperative Methadone for Postoperative Pain Control

NCT ID: NCT05845359

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Methadone group

Patients in this group will receive intraoperative methadone.

Group Type EXPERIMENTAL

Methadone

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Other Identifiers

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2022-14040

Identifier Type: -

Identifier Source: org_study_id

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