Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Record narcotic usage, in morphine equivalents, during postoperative inpatient hospital stay.
研究概览
简要总结
The purpose of this study is to clarify the efficacy of a multidrug versus single drug periarticular injection when only standard operative and postoperative pain management protocols used and the control group is exposed to what our investigators believe is the standard of care, single medication periarticular injection
详细描述
Study Objectives The intraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution will be compared to an injection of 30 mL of a 0.25% solution bupivacaine with ORA: 15101602-IRB01 Date IRB Approved: 3/16/2016 epinephrine and 30 mL 0.25% bupivacaine without epinephrine as an intraoperative periarticular joint injection protocol. The study's data collection timeline begins at the pre-operative clinic visit. Data collection continues through the patient's discharge after the surgical procedure and until the first year postoperative visit examination of joint range of motion and patient satisfaction questionnaires.
Primary Objectives:
The primary objective is to evaluate the efficacy of a multidrug versus bupivacaine intraoperative injection in decreasing total hip arthroplasty postoperative pain. To determine this, postoperative analgesic consumption will be collected for each patient and the value when converted to morphine equivalents will be compared between cohorts.
Analysis of morphine equivalent values at various postoperative time intervals (0-6 hours, 6-12 hours, 12-18, 18-24, then each postoperative day) and total morphine equivalent consumption for the entire length of stay will be performed between treatment cohorts.
Secondary Objectives:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be male or female of any race
- •Ages 18-80 years old
- •Patients must have a primary hip arthroplasty by principal investigator or co-investigator
- •Exclusion Criteria
- •Allergy or intolerance to the study materials
- •Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
- •History of previous surgeries on the affected joint other ORA: 15101602-IRB01 Date IRB Approved: 3/16/2016 than arthroscopy (open surgeries)
- •History of or current substance abuse or addiction
- •History of or current psychiatric diagnosis
- •Failure in collecting a required data point during study
排除标准
- 未提供
研究组 & 干预措施
Combination Medication Injection
Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution
干预措施: Ropivacaine (Drug)
Combination Medication Injection
Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution
干预措施: Ketorolac (Drug)
Combination Medication Injection
Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution
干预措施: Clonidine Injection (Drug)
Single Medication Injection
Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine and 30 mL 0.25% bupivacaine without epinephrine
干预措施: Bupivicaine + epinephrine (Drug)
Single Medication Injection
Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine and 30 mL 0.25% bupivacaine without epinephrine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Record narcotic usage, in morphine equivalents, during postoperative inpatient hospital stay.
时间窗: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Narcotic usage
次要结局
- Record time to achieve physical therapy milestones during inpatient physical therapy(From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first)
- Record VAS values during postoperative period(From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first)
- Length of hospital stay(From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first)
研究者
Brett Levine, MD
Associate Professor
Rush University Medical Center