Intraoperative Methadone for Postoperative Pain Control

Sponsor

Montefiore Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05845359

Collaborator

(none)

174

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate	Drug: Methadone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methadone group Patients in this group will receive intraoperative methadone.	Drug: 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.
No Intervention: Control group Patients in this group will receive saline (placebo), instead of methadone

Arm

Intervention/Treatment

Experimental: Methadone group

Patients in this group will receive intraoperative methadone.

Drug: 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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

Postoperative opioid use [24 hours postoperatively]
Total postoperative opioid use (MME)

Secondary Outcome Measures

Postoperative opioid use [48 hours and 2 weeks]
Total postoperative opioid use (MME)
Respiratory interventions [4 hours postoperatively]
Respiratory interventions needed postoperatively in the PACU (Post-anesthesia care unit)
Length of hospital stay [5 days]
International Pain Outcomes score [24 hours]
Questionnaire done on POD 1 (Post-Operative Day 1)
Pain scores [2 days]
Numeric pain scores postoperatively
POSS [2 days]
Pasero Opioid-induced Sedation Scale (POSS) in the PACU and on the floor
Opioid-related side effects [2 days]
includes nausea, vomiting, urinary retention, necessity of supplemental oxygen
Time to first ambulation [2 days]
GI recovery [2 days]
time taken for return of bowel function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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 OSA (Obstructive Sleep Apnea) 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Montefiore Medical Center

Investigators

Principal Investigator: Jennifer Choi, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT05845359

Other Study ID Numbers:

2022-14040

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Montefiore Medical Center

methadone

bariatric surgery

pain management

Additional relevant MeSH terms:

Pain, Postoperative

Methadone

Study Results

No Results Posted as of May 6, 2023