NCT04990804

Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing 1-3 level Anterior Cervical Discectomy and Fusion (ACDF) at the levels between C2 and T1 will be enrolled into this randomized prospective study. All patients enrolled in this study will undergo a trial of non-surgical treatment prior to the recommendation for surgery. After enrollment, patients will be randomized utilizing a block randomization strategy to one of two treatment groups - a standard opioid-containing postoperative pain regimen versus a non-opioid postoperative pain regimen. Postoperative outcomes will be assessed.

Detailed description

Patients will be followed for 12 months and the following Specific Aims will be assessed: Aim 1: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to lower rates of new chronic opioid use when compared with postoperative pain regimens utilizing opioids. Aim 2: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF results in equivalent postoperative pain scores in the early postoperative period. Aim 3: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to equivalent clinical outcomes when compared with postoperative pain regimens utilizing opioids at 3 months and 12 months. Aim 4: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to fewer postoperative complications when compared with postoperative pain regimens utilizing opioids.

Conditions

• Opioid Use
• Spinal Diseases
• Surgery--Complications
• Surgery
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Opioid Analgesic	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.
DRUG	Opioid-Free Postoperative Pain Regimen	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.

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2021-08-05
• Last updated: 2024-01-31
• Results posted: 2024-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study