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Methadone in THA for Post-op Pain and Opioid Reduction

NCT ID: NCT07227064

Last Updated: 2025-11-12

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

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-31

Brief Summary

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This randomized, double-blind controlled trial investigates whether intraoperative intravenous methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total hip arthroplasty under spinal anesthesia with mepivacaine. The primary outcome is patient-reported pain on a visual analog scale (VAS) 30-60 minutes after arrival in the post-anesthesia care unit (PACU). Secondary outcomes include opioid use, pain scores over time, incidence of nausea/vomiting, and quality of recovery. A total of 162 subjects will be enrolled at MUSC surgical sites.

Detailed Description

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Conditions

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Post Operative Pain Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Methadone

Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.

No Methadone

Patients will NOT receive methadone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Methadone

Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages 18-75 years of age
* Undergoing elective primary total hip arthroplasty with mepivacaine in the spinal anesthesia

Exclusion

* Allergy to methadone or mepivacaine
* Severe liver disease defined as Child's Pugh Class C
* End stage renal disease requiring dialysis
* Known diagnosis of prolonged QT syndrome
* Currently pregnant
* Unable to provide written, informed consent
* Non-English speaking
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Christopher Fatora, MD

Assistant Professor-Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Fatora, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Central Contacts

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Haley Nitchie, MHA

Role: CONTACT

Phone: 843-792-1869

Email: [email protected]

Other Identifiers

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Pro00147100

Identifier Type: -

Identifier Source: org_study_id