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Opioid Analgesic

Methadone for Pain Management After Spinal Surgery

Phase 2 & 3

Waitlist Available

Led By Shobana Rajan, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of discharge (about 6 days after surgery)

Awards & highlights

Study Summary

This trial examines if methadone can reduce post-surgery opioid use in people who have spine surgery.

Who is the study for?

This trial is for adults having complex spine fusion surgery, including revisions. It's not suitable for individuals with a body mass index (BMI) over 40.Check my eligibility

What is being tested?

The study tests if using methadone during and after spine surgery can prevent long-term opioid use compared to a placebo. Methadone or placebo is given intravenously in surgery, then orally or IV post-surgery.See study design

What are the potential side effects?

Methadone may cause side effects like nausea, drowsiness, constipation, and potential dependency issues when used as part of pain management.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postop days 1 and 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postop days 1 and 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and postop days 1 and 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of study design as assessed by number of participants for which safety was able to be assessed (EKGs)

Feasibility of study design as assessed by the number of participants for which postop opioid usage could be surveyed at 3 months

Feasibility of study design as assessed by the number of participants for which safety was able to be assessed (respiratory events)

+1 more

Secondary outcome measures

Number of participants for which opioid usage was able to be collected

Safety as assessed by the number of participants with Antiemetic use

Safety as assessed by the number of participants with dizziness

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Postoperative methadoneExperimental Treatment2 Interventions

Group II: Postoperative placeboPlacebo Group2 Interventions

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,947 Total Patients Enrolled

Shobana Rajan, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

1 Previous Clinical Trials

142 Total Patients Enrolled

Media Library

Postoperative methadone (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05693675 — Phase 2 & 3

Spinal Surgery Research Study Groups: Postoperative methadone, Postoperative placebo

Spinal Surgery Clinical Trial 2023: Postoperative methadone Highlights & Side Effects. Trial Name: NCT05693675 — Phase 2 & 3

Postoperative methadone (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693675 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a lower age limit for participation in this trial?

"People aged 18 and over, but under 70 are being invited to take part in this clinical trial."

Answered by AI

Are there any qualifications a person must meet to join this research project?

"This medical study seeks to enrol 30 adults aged 18-70 who have recently undergone multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries."

Answered by AI

Are there still opportunities for patients to take part in this clinical trial?

"Per the records on clinicaltrials.gov, this trial initially announced its recruitment period on February 1st 2023 and has not been updated since January 11th 2023. Consequently, patient enrolment is currently suspended; however there are 5 other trials actively recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Shobana Rajan 2023. "Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05693675.