A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Perioperative Opioid Use
研究概览
简要总结
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects.
The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function [quicker ambulation with physical therapy (PT), earlier return to work, etc.].
详细描述
Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows:
- Specific Aim 1: Determine the impact of IV ketorolac or IV acetaminophen use on immediate postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the Opiate-Related Symptom Distress Scale (ORSDS)
- Specific Aim 2: Determine the impact of IV ketorolac or IV acetaminophen use on functional outcomes defined by return to work, Oswestry Disability Index (ODI) and the Veterans Rand-12 (VR-12) Health Survey
The primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. The investigators hypothesize that patients in Group A and Group K will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75
- •Require 1 or 2 level lumbar spinal fusion through posterior or lateral approach
- •No history of long term opioid use (daily or almost daily opioid use > 2 weeks) and not on opiates at time of presentation to clinic
排除标准
- •Documented allergy to NSAIDs or Acetaminophen
- •History of: Peptic Ulcer Disease, Congestive heart failure, Chronic liver disease, Elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) greater than 1.5 times control, Bleeding disorder, Renal dysfunction (Serum creatinine > 1.5 mg/dL), Glucocorticoid use within 1 month of surgery
- •Current smokers (quite date < 30 days ago)
- •Revision for pseudarthrosis
- •Patients who are unable to physically or mentally provide consent to the study procedures.
研究组 & 干预措施
Intravenous (IV) Placebo
IV Placebo arm
干预措施: Placebo (Drug)
IV Ketorolac
IV Ketorolac arm
干预措施: Ketorolac (Drug)
IV Acetaminophen
IV Acetaminophen arm
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Perioperative Opioid Use
时间窗: Hospital stay (2-4 days)
Measure the impact of treatment on total opioid use during the hospital stay
次要结局
- Brief Pain Inventory(1 day and 3 days)
- Days to Walk 50 ft With PT(Hospital Stay (1-4 days))
- Opioid Use at 3 Months(3 months)
- Opioid Use at 4-6 Weeks(4-6 weeks)
- Numerical Pain Rating Scale(2 year follow up)
- Opioid Related Side Effects(Hospital Stay (1-4 days))
- Perioperative Complications - Transfusion Rate(Hospital Stay (1-4 days))
- Opioid Use at 1 Year(1 year)
- Veterans Rand - 12(2 year follow up)
- Perioperative Complications - Drain Output(Hospital Stay (1-4 days))
- Oswestry Disability Index(2 year follow up)
- Opioid Use at 2 Years(2 years)
- Length of Stay(Hospital Stay (1-4 days))
- Return to Work(2 year follow up)