Postoperative Analgesia After Cardiac Surgery - A Double-Blind, Prospective and Randomized Comparison of Wound Infiltration With Liposomal Bupivacaine and Bupivacaine Hydrochloride
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative Pain Intensity
研究概览
简要总结
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
详细描述
There are no studies to date on the use of LB infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. Moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. Other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. On the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation in double-blind fashion
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
- •Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass)
- •Surgery with the use of cardiopulmonary bypass
排除标准
- •Minimally invasive heart surgery through thoracotomy approach
- •Patient undergoing procedures under deep hypothermic circulatory arrest
- •Patients with active infections such as infective endocarditis
- •Emergency surgery
- •Patients undergoing transplantations and ventricular assist device insertion
- •Patients on any mechanical circulatory support preoperatively
- •Patient's refusal
- •End stage liver or renal disease
- •Allergy to bupivacaine
- •Patient who cannot understand the study procedure or refuse to participate
- •Redo-sternotomy
- •Participation in another study
- •Patients with severe right or left ventricular dysfunction (EF< 25%)
- •Patients requiring chronic opioids for chronic pain condition
研究组 & 干预措施
Exparel Injectable Product
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).
干预措施: Exparel Injectable Product (Drug)
Bupivacaine Hydrochloride
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Post-operative Pain Intensity
时间窗: NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively
Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement
Total Narcotic Consumption
时间窗: 0-72 hours post-operative period
All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.
次要结局
- Post-operative Nausea and Vomiting(From time of end of surgery to 72 hours post-operatively)
- Use of Incentive Spirometry(From time of end of surgery to 72 hours post-operatively)
- Non-invasive Ventilation (NIV) Requirement(From time of end of surgery to 72 hours post-operatively or until hospital discharge)
- Major Organ Dysfunction(From date of surgery assessed up to 30 day post-operatively)
- Time to Extubation(From the end of surgery until the patient is extubated up to 72 hours post-operatively)
- Patient Time to Out of Bed to Chair(From time of end of surgery to time of mobilization up to 72 hours post-operatively)
- Patient Time to Oral Intake(From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge)
- Re-intubation(From time of end of surgery to patient discharge up to one week)
- Length of Hospital and ICU Stay(From date of surgery assessed up to 30 day post-operatively)
- Patient Time to Mobilization(From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*)
- Hospital Readmission(From end of surgery assessed up to 30 days post-operatively)
- Mortality(From end of surgery assessed up to 30 days post-operatively)
研究者
Kathirvel Subramaniam
Principal Investigator, Associate Professor
University of Pittsburgh