Phase 3 Study Comparing Transversus Abdominis Plane Block After Caesarian Section Usin Bupivacaine 0.5% vs. Bupivacaine 0.25% vs. Placebo (Normal Saline).
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain
研究概览
简要总结
Adding TAP block with Bupivacaine may decrease the use of PCA bolus use after caesarean section for pain relief.
详细描述
Participants in the study will be randomized to TAP block with 0.5% or 0.25% bupivacaine or with placebo (normal saline).
The number of PCA bolus used within 24 hours post cesarean section will be compared between the groups.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant (ASA II) patients presenting for planned Cesarean delivery at New York Methodist Hospital under combined spinal epidural anesthesia
排除标准
- •They are unable or are unwilling to take part in the study
- •They have a history of allergy to any of the medications to be used in the study
- •They have a history of drug abuse or chronic pain or opioid use
- •They weigh less than 60kg
- •They have a multiple gestation, placental disease, preeclampsia other disease of pregnancy
- •They have a contraindication to neuraxial anesthesia (i.e., bleeding problems, bacteremia, etc.)
- •They are unable to understand instructions or questions related to the study
- •ASA III or IV
研究组 & 干预措施
Bupivicaine 0.5%
Drug Bupivacaine 0.5%
干预措施: Bupivicaine (Drug)
Bupivicaine 0.25%
Drug Bupivacaine 0.25%
干预措施: Bupivicaine (Drug)
Normal Saline
Saline Normal
干预措施: Bupivicaine (Drug)
结局指标
主要结局
Transversus Abdominis Plane (TAP) Block for Post Caesarean Pain
时间窗: The first post operative 24 hours
In Patient Controlled analgesia (PCA) system, the patient receives a preset dose of morphine by pressing a button on a computerized pump that is connected to an IV catheter. With PCA the patient may receive a small continuous flow of morphine and add more morphine as needed to provide a more constant level of comfort. In this study, we will compare the number of PCAs used by the participants in each arm
次要结局
- Decrease in the pain score as measured by Visual Analog Scale (VAS)(The first post operative 24 hours)
研究者
Joel Yarmush
Anesthesiologist
New York Presbyterian Brooklyn Methodist Hospital