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

NCT04990804 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 210432
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• New Chronic Opioid Use

  Opioid prescription for \> or = 45 days in 90 day window (9-12 months postoperatively)

  9-12 months

Secondary Outcomes (6)

• Postoperative Pain

  Postoperative day 1, 7, 14

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

  3 and 12 months postoperatively

• Neck Disability Index (NDI)

  3 and 12 months postoperatively

• Return to Work Status

  3 and 12 months postoperatively

• Patient Satisfaction With the Surgical Outcome

  3 and 12 months postoperatively

Study Arms (2)

Standard Perioperative Pain Regimen

ACTIVE COMPARATOR

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 Analgesic

Opioid-Free Perioperative Pain Regimen

EXPERIMENTAL

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.

Drug: Opioid-Free Postoperative Pain Regimen

Interventions

Opioid Analgesic DRUG

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.

Standard Perioperative Pain Regimen

Opioid-Free Postoperative Pain Regimen DRUG

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.

Opioid-Free Perioperative Pain Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographic evidence of degenerative cervical spine disease
• Failure of conservative therapy
• Age ≥18 years
• Skeletal maturity.

You may not qualify if:

• 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?

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Cervical Spine Research Society: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Spinal Diseases; Pain, Postoperative

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Research Coordinator
• Organization: Vanderbilt University Medical Center

kennadie.long@vumc.org

615-936-7107

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, Non-Blinded

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 5, 2021
• Study Start: August 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)