Clinical trial NCT04990804: Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery
Official title: Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Opioid Use
Spinal Diseases
Surgery--Complications
Surgery
Postoperative Pain
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Cervical Spine Research Society
First posted: 2021-08-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Non-Blinded
Primary purpose: TREATMENT

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.

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?

Primary outcomes:
measure: New Chronic Opioid Use
timeFrame: 9-12 months
Secondary outcomes:
measure: Postoperative Pain
timeFrame: Postoperative day 1, 7, 14
measure: PROMIS-29 (Patient-Reported Outcomes Measurement Information System)
timeFrame: 3 and 12 months postoperatively
measure: Neck Disability Index (NDI)
timeFrame: 3 and 12 months postoperatively
measure: Return to Work Status
timeFrame: 3 and 12 months postoperatively
measure: Patient Satisfaction With the Surgical Outcome
timeFrame: 3 and 12 months postoperatively
measure: Postoperative Adverse Events
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: