Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Morphine Equivalents at 72 Hours
研究概览
简要总结
The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.
详细描述
After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.
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
The only people who will be unblinded are the members of the block team, who are not members of the care team nor the study team. They will open the envelopes, draw up the medications and cover the syringes with opaque paper such that no one can tell the contents.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Not pregnant
- •Weight over 50kg presenting for open myomectomy
- •No history of allergy to any study medication
- •No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
- •No history of drug or alcohol use or abuse disorder or pre-existing liver disease.
排除标准
- 未提供
研究组 & 干预措施
Bupivacaine TAP
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
干预措施: Bupivacaine (Drug)
Bupivacaine TAP
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
干预措施: normal saline (Drug)
Liposomal bupivacaine TAP
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
干预措施: Bupivacaine (Drug)
Liposomal bupivacaine TAP
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
干预措施: Bupivacaine liposome (Drug)
Liposomal bupivacaine TAP
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
干预措施: normal saline (Drug)
结局指标
主要结局
Morphine Equivalents at 72 Hours
时间窗: 72 hours
Total cumulative opiates consumed converted to morphine equivalents
次要结局
- Area under the curve pain scale at 96 hours(96 hours)
- Quality of Recovery at 48 hours(48 hours)
- Morphine Equivalents at 96 Hours(96 hours)
- Morphine Equivalents at 48 Hours(48 hours)
- Opiate Sparing Criteria at 72 hours(72 hours)
- Quality of Recovery at 72 hours(72 hours)
研究者
Daniel Katz
Associate Professor
Icahn School of Medicine at Mount Sinai