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Opioid-Free Postoperative Pain Regimen for Postoperative Pain

Phase 4

Waitlist Available

Research Sponsored by Vanderbilt University Medical Center

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 9-12 months

Awards & highlights

Study Summary

This trial is testing two different post-operative pain regimens for patients undergoing ACDF surgery.

Eligible Conditions

Postoperative Pain
Spinal Diseases
Opioid Use Disorder
Surgery Complications
Surgery

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

New Chronic Opioid Use

Secondary outcome measures

Neck Disability Index (NDI)

PROMIS-29 (Patient-Reported Outcomes Measurement Information System)

Patient Satisfaction With the Surgical Outcome

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Opioid-Free Perioperative Pain RegimenExperimental Treatment1 Intervention

Patients will receive no opioids. Pain will be managed with Acetaminophen 1000mg q8 hours, Ketorolac 10mg every 6 hours (for 5 days), Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily, and a muscle relaxer (Methocarbamol 750mg BID or Cyclobenzaprine 5-10 mg TID) all to be taken as scheduled for the first 2 weeks (except Ketorolac - 5 days) postoperatively as side effects permit. Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID) may be utilized if contraindications to Ketorolac exist. Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.

Group II: Standard Perioperative Pain RegimenActive Control1 Intervention

Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,149 Total Patients Enrolled

3 Trials studying Postoperative Pain

274 Patients Enrolled for Postoperative Pain

Cervical Spine Research SocietyOTHER

3 Previous Clinical Trials

155 Total Patients Enrolled

Frequently Asked Questions

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

Are participants being enrolled in this experiment currently?

"Yes, this trial is still looking for participants. The clinicaltrial was first announced on August 1st, 2021 and has since been updated February 9th, 2022."

Answered by AI

How many test subjects are taking part in this experiment?

"The information available on clinicaltrials.gov supports that this trial is open and presently recruiting patients. The study, which began enrolling participants on 8/1/2021, is looking for 80 individuals across 1 site."

Answered by AI