Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients

Summary

Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and demonstrates slow onset to withdrawal. The literature comparing methadone to more commonly used post-operative narcotics demonstrates that it manages pain better, sustains consistent plasma concentrations, decreases overall narcotic requirement, results in no additional adverse events, and is safe, even in children, across several studies. Since the standard of care is non-methadone narcotic usage to manage the significant pain of complex spinal surgery cases, it is understandable that methadone could be a desirable alternative to promote sustained pain control and early ambulation in these patients. The goal of this study is to compare the effect of a single dose of methadone administered intraoperatively in enrolled spinal fusion patients to their historical controls given fentanyl and morphine, and determine if more sustained pain control during the first few days after surgery provides a better subjective experience for the patient with less pain, which allows them to ambulate and leave the hospital sooner than patients given a standard regimen.

Conditions

• Pain, Postoperative

Interventions

DRUG

Methadone Hydrochloride

IV administration of methadone intra-operatively for a single dose

OTHER

Standard pain regimen

Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine

PROCEDURE

Spinal Fusion Surgery

Clinically-indicated spinal fusion surgery

DRUG

Dexamethasone

Post operative swelling and pain control

DRUG

Ketamine

Perioperative anesthesia medication

DRUG

Remifentanil

Perioperative pain medication

DRUG

Sufentanil

Perioperative pain medication

Sponsors & Collaborators

• Montefiore Medical Center

  lead OTHER

Principal Investigators

• Andrew J Kobets, MD, MHS · Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center

• Merritt D Kinon, MD · Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-07-29

Primary Completion

2020-11-10

Completion

2020-11-10

FDA Drug

Yes

Countries

• United States

Study Locations