A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.
研究概览
简要总结
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed below) for pain management intraoperatively.
详细描述
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period. Subjects scheduled for a planned total knee arthroplasty procedure will be consented and those meeting study criteria will be randomized to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a multi-drug cocktail, or a multi-drug cocktail alone.
This study will recruit subjects on an ongoing basis with a minimum of 130 study participants and a maximum of 156. Efficacy data on surgical pain control and safety data will be collected at frequent intervals during the hospitalization. Each study participant will be followed for a minimum 6 week follow-up period.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 88 years of age.
- •Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty.
- •Subject willing and able to sign the informed consent.
- •Subject is fluent in verbal and written English.
- •Subject agrees to take Liposomal bupivacaine or standard of care equivalent.
排除标准
- •Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted.
- •Subject is pregnant or planning to become pregnant while enrolled in the study.
- •Subject has a history of narcotic or alcohol abuse.
- •Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) < 30 ml/min within 30 days of surgery).
- •For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)
研究组 & 干预措施
Exparel plus multi-drug cocktail
Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.
干预措施: Liposomal bupivacaine, 266mg (Drug)
Exparel plus multi-drug cocktail
Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.
干预措施: Ketorolac 30mg (Drug)
Exparel plus multi-drug cocktail
Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.
干预措施: Morphine 10mg (Drug)
Exparel plus multi-drug cocktail
Liposomal bupivacaine, 266mg plus Bupivacaine 0.25% with Epinephrine, Ketorolac 30mg, and Morphine 10mg.
干预措施: Bupivacaine 0.25% with Epinephrine (Drug)
Multi-drug cocktail alone
Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.
干预措施: Bupivacaine 0.5 % with Epinephrine (Drug)
Multi-drug cocktail alone
Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.
干预措施: Ketorolac 30mg (Drug)
Multi-drug cocktail alone
Bupivacaine 0.5% with Epinephrine, Ketorolac 30mg, Morphine 10mg.
干预措施: Morphine 10mg (Drug)
结局指标
主要结局
Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24.
时间窗: VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24.
The area under the curve (AUC) of the VAS scores from 4-24 hours will be compared between the two treatment groups.
Patient reported VAS pain intensity score. Post-surgery hours 24-48.
时间窗: VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge.
The AUC of the VAS scores from 24-48 hours or until discharge will be compared between the two treatment groups.
Patient reported VAS pain intensity score. Post-surgery hours 48-72.
时间窗: VAS pain intensity scores will be collected starting 48 hours after end of surgery and every 4 hours thereafter until hour 72, or discharge.
The AUC of the VAS scores from 48-72 hours or until discharge will be compared between the two treatment groups.
次要结局
- Cost:benefit analysis(TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits.)