Laparoscopic Assisted Plane Block (LAPB) Trial: Bupivacaine Versus Liposomal Bupivacaine Versus Standard Local Anesthesia for Post-operative Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Narcotic Usage
研究概览
简要总结
This study attempts to demonstrate improvement in analgesia in a more diverse laparoscopic surgery group with the use of laparoscopic assisted transversus abdominis plane blocks. The investigators will compare bupivacaine (treatment arm 1) versus liposomal bupivacaine (treatment arm 2) versus port site injection of local anesthesia with injection of saline placebo (control). The hypothesis is that liposomal bupivacaine will result in improved analgesia when compared to bupivacaine LAPB and control. The investigators further hypothesize that bupivacaine LAPB will be more effective than the control.
详细描述
Patients will either be pre-screened prior to their pre-operative appointment for eligibility, or screening will occur on the day of surgery. Informed Consent will be obtained from amenable, eligible patients prior to their operation by a member of the research team. A study number will be assigned, and the patient will be randomized to a treatment group. The patients will not be aware to which treatment group they have been randomized.
After consent is obtained and randomization has been completed, the operating room registered nurse will calculate maximum dose of allowable bupivacaine per patient based on body weight. Anesthesia will provide the intravenous lidocaine bolus on induction to all patients without a contraindication to the medication. The port placement will occur using a needle to raise skin/preperitoneal wheal*. Up to 20cc of 1% lidocaine/epinephrine will be divided among all ports and stab incisions. At end of case, no further skin or port-specific preperitoneal anesthetic will be injected unless a skin incision was extended.
For patients randomized to port site injection (Control): 60 cc of sterile, preservative-free, injectable saline will be given as a placebo per the protocol in item 6.
For patients randomized to bupivacaine plain LAPB (Treatment Arm 1): The maximum weight-based dose of plain bupivacaine will be diluted with sterile, injectable, preservative-free saline to a total of 60cc with a maximum of 250mg bupivacaine (regardless of weight) and loaded into a 30cc syringe with a 22g spinal needle (one 30cc syringe used for each side).
For patients randomized to liposomal bupivacaine LAPB (Treatment Arm 2): The maximum dose for adult patients is 266mg (20mL) of liposomal bupivacaine. This will be diluted with 40cc of preservative-free normal saline for injection, per manufacturer recommendations. The solution will then be loaded into a 30cc syringe with a 22g spinal needle and injected in the same fashion as the bupivacaine plain LAPB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
single-blind study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-80 years old
- •Patients undergoing non-emergent laparoscopic surgery with planned or continued admission for at least 1 night
- •Patients who receive fully laparoscopic procedures including ports up to 15mm, and any blunt dilation of port fascia or sharp extension of skin incisions for specimen extraction.
排除标准
- •Patients under 18 or over 80 years old
- •Patients who are pregnant
- •Patients who are unable to consent themselves
- •Patients who undergo an appendectomy for acute appendicitis
- •Patients who undergo emergent surgery
- •Patients who are converted to open procedure
- •Patients who receive concurrent neuraxial anesthesia (spinal, epidural, or indwelling pain pumps)
- •Patients who receive concurrent local anesthetic drips planned during or administered immediately after surgery
- •Patients who have a contraindication to local anesthetics (e.g. verified allergy, severe hepatic dysfunction)
- •Patients who use chronic narcotics
研究组 & 干预措施
bupivacaine block
laparoscopic assisted plane block of standardized dose of bupivacaine plain
干预措施: Bupivacaine (Drug)
liposomal bupivacaine block (Exparel 266 milligram Per 20 ML)
laparoscopic assisted plane block of standardized dose of bupivacaine plain
干预措施: Exparel 266 milligram Per 20 ML Injection (Drug)
saline block
laparoscopic assisted plane block with placebo saline injection
干预措施: Saline (Drug)
结局指标
主要结局
Narcotic Usage
时间窗: 24 hours
post-operative narcotic usage expressed in morphine equivalents
次要结局
- Narcotic Usage(7 days)
- Pain Scores(24 hours)
- Post-Operative Nausea(24 hours)
- Post-operative emesis(24 hours)