A Double Blind, Randomized Clinical Trial Comparing Postoperative Narcotic Usage in Patients Receiving Periarticular Liposomal Bupivicaine vs. Those Patients Receiving Standard Periarticular Joint Injections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 48 Hour Post-surgical Opioid Use
研究概览
简要总结
This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study) group will use less opioid in the first 48 hours post-operatively than the control group.
详细描述
Opioids have been prescribed with increasing frequency for non-acute, non-cancer pain in the last 15 years. Because of this, opioid tolerance in the general population has grown markedly, and opioid tolerant patients can be especially difficult to manage in the perioperative period. In general, they require much higher doses of opioids to obtain similar levels of pain-control compared to opioid-naïve patients and are susceptible to respiratory depression and other adverse events. This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty.
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
- Double (Care Provider, Investigator)
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
- •Males and Females age 18+ years old having total knee arthroplasty at UCI
- •Meet at least one of the following criteria "opioid tolerant":
- •Taking 50mg oral morphine equivalent or more per day
- •On long-acting opioids (fentanyl pathc, oxycontin, methadone, etc.)
- •Being followed by a chronic pain physician
- •All subjects must be free of renal or hepatic dysfunction; defined as:
- •Glomerular filtration rate >60 mL/min/1.73m^2
- •AST & ALT <150, total bilirubin <1.0, INR <1.3 (if not taking anticoagulants)
- •No active hepatitis, no jaundice
- •Control group- received standard periarticular injection Research group- receives Exparel injection
排除标准
- •Allergy to local Anesthetic
- •Pregnancy
- •Nursing mothers
- •Children<18 years of age
- •Renal impairment (GFR<60 mL/min/1.73 m^2
- •Hepatic impairment (active hepatitis, elevated AST or ALT, jaundice)
- •Any history of ventricular arrhythmia or supraventricular tachycardia, or myocardial infarction within the last six months.
研究组 & 干预措施
EXPAREL® Bupivacaine Liposome Suspension
Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-Liposomal Bupivicaine will be administered at the end of the surgery. A new sustained-release local anesthetic solution (Bupivacaine Liposome Injectable Suspension) will be injected into the soft tissues around the join after surgery. Exparel is a novel-composition of bupivacine in which the drug is dissolved into liposomes which release it slowly over a period of 72 hours.
干预措施: (Bupivacaine Liposome Injectable Suspension) (Drug)
Standard periarticular joint injection
A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
干预措施: Standard Preparation (Drug)
结局指标
主要结局
48 Hour Post-surgical Opioid Use
时间窗: 48 hours
A comparison of group means between the control group and study group with regards to 48 hour opioid use.
次要结局
- Average Daily Patient Pain Score(Up to 48 hours)
- Average Daily Opioid Use During Admission(Up to 48 hours)
- Recovery Room Opioid Use(Up to 48 hours)
- Post-operative Complications(Up to 1 month)
研究者
Joseph Brian Rinehart
Assistant Professor of Clinical Anesthesiology
University of California, Irvine