A Randomized, Prospective Trial Comparing Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- The visual pain scale from 1-10 will be used to determine changes in pain control at 3, 12, 24, and 48 hour time intervals postoperatively.
研究概览
简要总结
A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either:
- a local cocktail.
- a local cocktail plus Exparel.
- marcaine plus Exparel prior to wound closure following knee arthroplasty.
详细描述
As an alternative to the various injection cocktails, Exparel, a liposomal-coated bupivicaine, was introduced as a long-acting form of bupivicaine, a local anesthetic. This new technology has been utilized by numerous orthopedic joint surgeons. Since its introduction there have been studies showing varying results in terms of postoperative pain control.
Therefore, it is our purpose to conduct a prospective, randomized control study to compare postoperative pain control in a series of patients treated with either:
- a local cocktail.
- a local cocktail plus Exparel.
- marcaine plus Exparel prior to wound closure following knee arthroplasty.
METHODOLOGY
Subjects will be randomized preoperatively into three different groups on total knee subjects done at three different facilities. This study is single blinded study. The visual pain scale from 1-10 will be used to determine pain control at 3, 12, 24, and 48 hour time intervals postoperatively. Postoperative narcotic use will also be monitored at the same time intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Institutional Review Board (IRB) review has been conducted and approval of the study has been obtained
- •The subject underwent a primary total knee replacement under adductor canal block with general anesthesia
排除标准
- •The subject is a minor
- •The subject is on chronic narcotics
- •The subject has an indwelling pain pump
- •The subject is having a knee revision surgery
- •The subject is having a partial knee replacement
- •The subject has a history of sepsis in a previously replaced joint
- •The subject has back pain
- •The subject has radicular pain
- •The subject suffers from depression
- •The subject has fibromyalgia
- •The subject is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims
研究组 & 干预措施
Randomized Group A [Cocktail Injection]
COCKTAIL INJECTION:
Cocktail Injection Consists of:
Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1 mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose
干预措施: Cocktail (Drug)
Randomized Group B [Cocktail Injection Plus Exparel]
COCKTAIL INJECTION PLUS EXPAREL:
Cocktail Injection Consists of:
Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose
Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose
干预措施: Cocktail (Drug)
Randomized Group B [Cocktail Injection Plus Exparel]
COCKTAIL INJECTION PLUS EXPAREL:
Cocktail Injection Consists of:
Ropivacaine (Brand Name: Naropin) 5 mg/ml (49.25 ml) Ketorolac (Brand Names: Toradol, Sprix, Acuvail, Acular) 30 mg/ml (1 ml) Epinephrine (Brand Names: EpiPen, Adrenaclick, Medihaler-Epi, Twinject) 1 mg/ml (0.5 ml) Clonidine (Brand Names: Kapvay, Catapres, Duraclon, Nexiclon) 0.1mg/ml (0.08 mg = 0.8 ml) Normal Saline added to total of 100 cc Dosage Form: Injection Dosage: See above Frequency: Single dose
Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose
干预措施: Exparel (Drug)
Randomized Group C [Marcaine Plus Exparel]
MARCAINE PLUS EXPAREL:
Bupivacaine Hydrochloride (Brand Name: Marcaine, Sensorcaine) Dosage Form: Injection Dosage: 3 ml vial, 0.5% solution Frequency: Single dose
Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose
干预措施: Exparel (Drug)
Randomized Group C [Marcaine Plus Exparel]
MARCAINE PLUS EXPAREL:
Bupivacaine Hydrochloride (Brand Name: Marcaine, Sensorcaine) Dosage Form: Injection Dosage: 3 ml vial, 0.5% solution Frequency: Single dose
Bupivacaine Liposome (Brand Name: Exparel) Dosage Form: Injection Dosage: 20 ml Single use vial, 1.3% (13.3 mg/ml) Frequency: Single dose
干预措施: Marcaine (Drug)
结局指标
主要结局
The visual pain scale from 1-10 will be used to determine changes in pain control at 3, 12, 24, and 48 hour time intervals postoperatively.
时间窗: Pain control intervals will be assessed at 3, 12, 24, and 48 hour time intervals postoperatively.
次要结局
未报告次要终点