Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
研究概览
简要总结
The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.
详细描述
All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.
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 patient, surgical team, nursing team, anesthesia team, and outcomes assessor will be blinded to the group assignment. The anesthetist performing the TAP block will not be blinded to the group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.
排除标准
- •Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.
研究组 & 干预措施
Bupivacaine
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
干预措施: Bupivacaine (Drug)
Liposomal bupivacaine
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
干预措施: Liposomal bupivacaine (Drug)
Liposomal bupivacaine
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
干预措施: Saline (Drug)
Liposomal bupivacaine and bupivacaine
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
干预措施: Bupivacaine (Drug)
Liposomal bupivacaine and bupivacaine
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
时间窗: 0 - 72 hours post-operatively
Total opioid consumption
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
时间窗: 0 - 72 hours post-operatively
time to first opioid given
次要结局
- Number of Patients With Local Anesthetic Toxicity(0 - 72 hours post-operatively)
- Pain Scores Using Visual Analogue Scale ( 0-10)(0-24 postoperative pain scores)
- Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure(0 - 72 hours post-operatively)
- Length of Stay in the Hospital(until the patient is discharged from the hospital)
- Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied(0 - 72 hours post-operatively)
研究者
Mohamed Rida Alsaden
Anesthesiologist
Henry Ford Health System