Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Dose (in mg) of intrathecal 0.75% hyperbaric bupivacaine that provides effective analgesia in 90% of patients undergoing bilateral tubal ligation as measured by patient reported effectiveness.
研究概览
简要总结
The purpose of this study is to determine the dose of bupivacaine that provides effective pain management in 90% (ED90) of patients undergoing bilateral tubal ligation. This will guide anesthesiologists on the most effective dose to minimize intraoperative pain during this procedure. The goal is to make women as comfortable as possible when they undergo this procedure while also minimizing the amount of time they are required to remain in the hospital afterwards for monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age
- •American Society of Anesthesiology class II or III
- •bilateral tubal ligation
排除标准
- •patient refusal
- •BMI ≥ 50 kg/m2
- •American Society of Anesthesiology class IV or above
- •contraindication to neuraxial anesthesia
- •allergy to bupivacaine
研究组 & 干预措施
Hyperbaric bupivacaine 10.5mg
干预措施: Hyperbaric bupivacaine (Drug)
Hyperbaric bupivacaine 12mg
干预措施: Hyperbaric bupivacaine (Drug)
Hyperbaric bupivacaine 13.5mg
干预措施: Hyperbaric bupivacaine (Drug)
Hyperbaric bupivacaine 15mg
干预措施: Hyperbaric bupivacaine (Drug)
结局指标
主要结局
Dose (in mg) of intrathecal 0.75% hyperbaric bupivacaine that provides effective analgesia in 90% of patients undergoing bilateral tubal ligation as measured by patient reported effectiveness.
时间窗: End of study, up to 2 years
次要结局
- Numerical Pain Rating Scale (NPRS) during surgery(End of study, up to 2 years)
- Side effects(End of study, up to 2 years)
- Nausea(End of study, up to 2 years)
- Vomiting(End of study, up to 2 years)
- Itching(End of study, up to 2 years)
- Vasopressor use(End of study, up to 2 years)
- Patient satisfaction(End of study, up to 2 years)