Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Spine Surgery

Treatments: Drug: Postoperative methadone; Drug: Postoperative placebo; Drug: Rescue Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05693675

HSC-MS-22-0912

Details and patient eligibility

About

The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries

Exclusion criteria

• BMI greater than 40

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Postoperative methadone

Experimental group

Treatment:

Drug: Rescue Analgesia

Drug: Postoperative methadone

Postoperative placebo

Placebo Comparator group

Treatment:

Drug: Rescue Analgesia

Drug: Postoperative placebo