Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery
Condition: Opioid Use; Spinal Diseases; Surgery--Complications; Surgery; Postoperative Pain
MeSH terms: Spinal Diseases
Intervention: Opioid Analgesic; Opioid-Free Postoperative Pain Regimen
Intervention description: 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.; 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.
Intervention MeSH terms: Analgesics, Opioid; Analgesics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Non-Blinded
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Radiographic evidence of degenerative cervical spine disease

          -  Failure of conservative therapy

          -  Age ≥18 years

          -  Skeletal maturity.

        Exclusion Criteria:

          -  Preoperative chronic opioid use as determined by self report (>45 out of past 90 days)

          -  History of chronic kidney disease

          -  Revision cervical spine surgery

          -  Concurrent posterior cervical fusion

          -  Does the patient have an intolerance to NSAIDs (non-steroidal anti-inflammatory
             drugs)?

          -  Does the patient have any preexisting health condition the study physician believes
             will be exacerbated by participating in this study?