A Randomized Controlled Clinical Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Duration of Motor Block
研究概览
简要总结
This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor block and duration until meeting discharge criteria in patients undergoing cervical cerclage. The hypothesis is that chloroprocaine will result in faster resolution of motor block.
详细描述
Cervical cerclage is an ambulatory surgical procedure of short duration commonly performed under spinal anesthesia. Bupivaciane and chlororpocaine are both commonly used, but how their use impacts clinical care, in particular patient flow, is not well studied.
This is a prospective, randomized, double blind, controlled trial. Participants meeting inclusion criteria will be randomly allocated to receive spinal anesthesia with either chloroprocaine or bupivacaine.
Patients will then be assessed for motor block and sensory level until they are discharged from the recovery room.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The anesthesia provider responsible for the clinical care of the patient will be given an envelope prepared during randomization and instructed to open it and prepare the medication in a separate room, such that the investigator and patient cannot see which vial is being used to prepare the medication. The anesthesia provider will also be instructed not to reveal the allocation group to the investigator or the patient.
Both bupivacaine and chloroprocaine are clear liquids, and the intended doses of both medications are the same volume, to insure complete blinding.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA classification II or III females
- •Age: 18-45 years old
- •BMI ≤ 50 kg/m2
- •Singleton pregnancy
- •Simple prophylactic cervical cerclage
- •Planning neuraxial anesthesia
排除标准
- •Abdominal and complex cervical cerclage (e.g. bulging bag)
- •Contraindication to neuraxial anesthesia
- •Known hypersensitivity to chloroprocaine (a.k.a. Ester allergy), paraaminobenzoic acid (PABA) or bupivacaine (a.k.a. Amide allergy)
- •Pseudocholinesterase deficiency
- •Concomitant use with ergot-type oxytocic drugs
研究组 & 干预措施
Chloroprocaine
Patients assigned to chlorprocaine will receive a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
干预措施: Chloroprocaine (Drug)
Bupivacaine
Patients assigned to bupivacaine will receive a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Duration of Motor Block
时间窗: 6 hours
The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale: I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block
次要结局
- Duration of Sensory Block(6 hours)
- Time to Ambulation(6 hours)
- Time to Micturation(6 hours)