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

Phase 4

Terminated

Conditions: Spinal Diseases
Surgery--Complications
Opioid Use
Surgery
Postoperative Pain

Interventions: Drug: Opioid Analgesic
Drug: Opioid-Free Postoperative Pain Regimen

Registration Number: NCT04990804

Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

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?

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Perioperative Pain Regimen	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.
Opioid-Free Perioperative Pain Regimen	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.

Primary Outcome Measures

Name	Time	Method
New Chronic Opioid Use	9-12 months	Opioid prescription for \> or = 45 days in 90 day window (9-12 months postoperatively)

Secondary Outcome Measures

Name	Time	Method
Return to Work Status	3 and 12 months postoperatively
PROMIS-29 (Patient-Reported Outcomes Measurement Information System)	3 and 12 months postoperatively	A disease non-specific tool for measuring medication management, depression, anxiety, fatigue, pain interference, sleep disturbance, and phsyical functioning. Each domain contains questions specific to what trait is being measure. Scores have a mean of 50 and a standard deviation of 10. The higher the score, the better the outcome.
Postoperative Pain	Postoperative day 1, 7, 14	Numeric Rating Scale (NRS) arm pain and neck pain scores. This scale grades pain on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The higher the pain score, the more ineffective a patient's pain medication regimen is.
Neck Disability Index (NDI)	3 and 12 months postoperatively
Patient Satisfaction With the Surgical Outcome	3 and 12 months postoperatively	Ask the patient how satisfied they are will their surgical treatment and includes the following responses. 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied
Postoperative Adverse Events	Baseline to 12 months	Readmissions, adverse events, serious adverse events