Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OhioHealth
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Length of Stay in Hospital (Days)
研究概览
简要总结
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.
详细描述
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of osteoarthritis
- •Elected to undergo primary TKA, THA, or TSA
排除标准
- •Age < 18 years
- •Pregnant or breastfeeding
- •Non-English speaking
- •Unable to give informed consent
- •Previous open hip, knee or shoulder surgery
- •Pre-determined patients discharging to ECF
- •Patients with allergies to bupivacaine
- •Patients currently taking opioid pain medication
- •Patients with contraindication to nerve blocks
- •Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
- •Patients with severe hepatic disease
- •Patients with chronic heart disease as defined as a decreased ejection fraction
研究组 & 干预措施
Standard of care analgesia
Total Hip Arthroplasty (THA):
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
Total Knee Arthroplasty (TKA):
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
Total Shoulder Arthroplasty (TSA):
All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
干预措施: Standard of care analgesia (Drug)
Liposomal bupivacaine
THA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
干预措施: Liposomal bupivacaine (Drug)
Liposomal bupivacaine
THA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
干预措施: Standard of care analgesia (Drug)
结局指标
主要结局
Length of Stay in Hospital (Days)
时间窗: Participants were followed for the duration of hospital stay, an expected average of 3 days
次要结局
- Time to Post-operative Rescue Opioids (Hours)(Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days)
- Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days(Date of discharge through 30 days following discharge)
研究者
Deborah Napier
Clinical Outcomes Manager
OhioHealth