Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- New Chronic Opioid Use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic evidence of degenerative cervical spine disease
- •Failure of conservative therapy
- •Age ≥18 years
- •Skeletal maturity.
排除标准
- •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?
研究组 & 干预措施
Standard Perioperative Pain Regimen
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.
干预措施: Opioid Analgesic (Drug)
Opioid-Free Perioperative 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.
干预措施: Opioid-Free Postoperative Pain Regimen (Drug)
结局指标
主要结局
New Chronic Opioid Use
时间窗: 9-12 months
Opioid prescription for \> or = 45 days in 90 day window (9-12 months postoperatively)
次要结局
- PROMIS-29 (Patient-Reported Outcomes Measurement Information System)(3 and 12 months postoperatively)
- Return to Work Status(3 and 12 months postoperatively)
- Postoperative Pain(Postoperative day 1, 7, 14)
- Neck Disability Index (NDI)(3 and 12 months postoperatively)
- Patient Satisfaction With the Surgical Outcome(3 and 12 months postoperatively)
- Postoperative Adverse Events(Baseline to 12 months)
研究者
Amir Abtahi
Assistant Professor
Vanderbilt University Medical Center