A Prospective Randomized-controlled Study on Effectiveness of Extended-release Liposomal Bupivacaine in Postoperative Pain Control
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
研究概览
简要总结
The purpose of this study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions.
详细描述
Study Design:
This is a prospective, single-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing bupivacaine liposomal injectable suspension (Exparel®) versus regular bupivacaine hydrochloride (HCl).
Procedure:
In patients aged 18 and over who require sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions will be screened and consented for potential enrollment. Patients will be randomized following consenting to either Exparel® or regular bupivacaine hydrochloride group.
Course of Study:
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 (Participant, Investigator)
盲法说明
Masking included all patients, who were blinded to the contents of the intraoperative injection, as well as partial blinding of the surgical team who were masked from the treatment allocation up until the time of injection following which the knowledge of drug was inevitable as Exparel® has a milky appearance as opposed to the colorless bupivacaine hydrochloride (standard) formulations.
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
- •18 years-old or older, and
- •Sternotomy, thoracotomy, laparotomy or mini-thoracotomy incision is planned
- •There is reasonable expectation that the patient will be extubated within 24 hours after surgery
排除标准
- •The patient has a known allergy to morphine or any opioid
- •The patient has a known chronic pain disorder or takes daily opioid medication > 1 month prior to surgery
- •There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion
- •High postoperative morbidity index based on preoperative assessment, such as, low likelihood of extubation within 24 hours, extensive thoracoabdominal aortic aneurysm (Extent 2 TAAA), preoperative renal insufficiency/failure, etc.
研究组 & 干预措施
Exparel®
Patients in this group will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel® is an FDA-approved bupivacaine liposome injectable suspension produced by Pacira Pharmaceuticals.
干预措施: Exparel (Drug)
Exparel®
Patients in this group will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel® is an FDA-approved bupivacaine liposome injectable suspension produced by Pacira Pharmaceuticals.
干预措施: Patient Controlled Analgesia (PCA) (Drug)
Regular Bupivacaine
Patients in this group will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. The standard non-liposomal bupivacaine will be from Hospira pharmaceuticals
干预措施: Bupivacaine hydrochloride (Drug)
Regular Bupivacaine
Patients in this group will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. The standard non-liposomal bupivacaine will be from Hospira pharmaceuticals
干预措施: Patient Controlled Analgesia (PCA) (Drug)
结局指标
主要结局
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
时间窗: postoperative day 3
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
时间窗: postoperative day 3
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
时间窗: postoperative day 3
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
次要结局
- Overall Opioid Use(Over the first 72 hours after surgery)
- Mean Length of Hospital Stay(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Change From Baseline in Quality of Life(Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3)
- Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours(72 hours after surgery)
- Hospital Cost for Patient Care During Hospitalization(duration of hospital stay, an expected average of 4 weeks)
研究者
Kristofer Charlton-Ouw
Associate Professor, Department of Cardiothoracic and Vascular Surgery
The University of Texas Health Science Center, Houston