Clinical trial

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

Name

210432

Description

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.

Trial arms

Trial start

2021-08-01

Estimated PCD

2022-02-01

Trial end

2022-02-01

Status

Terminated

Phase

Early phase I

Treatment

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.

Arms:

Standard 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.

Arms:

Opioid-Free Perioperative Pain Regimen

Size

Primary endpoint

New Chronic Opioid Use

9-12 months

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?

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Non-Blinded', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

Updated at

2024-01-31

1 organization

2 products

5 indications

Organization

Vanderbilt University Medical Center

Product

Opioid Analgesic

Indication

Opioid Use

Indication