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Preoperative Opioid Taper for Spinal Fusion Surgery

N/A

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Indicated for lumbar, lumbosacral, or thoracolumbar spinal fusion surgery in the departments of Orthopedic Surgery and Neurosurgery

18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly, month 3, month 6

Awards & highlights

Study Summary

This trial is testing whether reducing patients' opioid use before surgery will reduce postoperative pain and improve patient outcomes.

Who is the study for?

This trial is for adults over 18 who are scheduled for spinal fusion surgery and have been using opioids daily for at least four weeks. It's not suitable for those unable to complete patient surveys or those taking Suboxone.Check my eligibility

What is being tested?

The study tests if tapering off opioids before spinal fusion surgery leads to less opioid use after surgery, reduced pain, and better recovery outcomes compared to patients who don't taper their opioid use.See study design

What are the potential side effects?

Potential side effects may include withdrawal symptoms from reducing opioid intake such as anxiety, insomnia, nausea, pain increase, and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am recommended for spinal fusion surgery in my lower or mid-back.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly, month 3, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly, month 3, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly, month 3, month 6 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from baseline Patient Reported Outcome Measures (PROMs)

Change in Numeric Pain Scale Score

Change in Postoperative Opioid Pain Medication Dose

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Opioid Taper GroupExperimental Treatment1 Intervention

Patients randomized to the taper group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive a scheduled tapering protocol, with a goal of 10-15% reduction in their weekly opioid use, along with weekly phone calls from a study coordinator assessing their ability to taper and pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures.

Group II: Control GroupActive Control1 Intervention

Patients randomized to the control group will have baseline pain score, opioid medication use, and patient reported outcomes 4-6 weeks prior to elective thoracolumbar, lumbar, or lumbosacral spinal fusion surgery. They will receive no recommendation or guidance in their preoperative opioid pain medication use, but will received weekly phone calls from a study coordinator assessing their preoperative pain scores. After surgery, they will receive 6 weekly phone calls from the coordinator, to assess their postoperative opioid medication use and pain scores. At the 6th week phone call, and 3 month and 6 month clinic postoperative clinic visits, they will also repeat patient reported outcome measures.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,473 Total Patients Enrolled

Media Library

Non-taper Control Clinical Trial Eligibility Overview. Trial Name: NCT04095624 — N/A

Opioid Use Disorder Research Study Groups: Control Group, Opioid Taper Group

Opioid Use Disorder Clinical Trial 2023: Non-taper Control Highlights & Side Effects. Trial Name: NCT04095624 — N/A

Non-taper Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04095624 — N/A

Frequently Asked Questions

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

How many participants are being enrolled in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this trial is actively seeking out individuals for enrollment. The study was first published in September of 2019 and its most recent update occurred in July 2022; 84 participants are required from one central location."

Answered by AI

Is there still an opportunity to join this experiment?

"According to clinicaltrials.gov, this trial is still calling for participants. The original posting of the study dates back to September 9th 2019 and was recently amended on July 10th 2022."

Answered by AI