Comparison of the Duration of Motor Block After Spinal Anesthesia for Planned Cesarean Sections: Hyperbaric Prilocaïne Versus Hyperbaric Bupivacaine
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- duration of motor block
研究概览
简要总结
The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.
详细描述
Prospective study, randomized into two parallel groups (Hyperbaric Prilocaïne versus hyperbaric Bupivacaine), double-blind, monocentric (Clinique Saint Roch in Montpellier).
The number of subjects required is 50 patients, 25 per group.
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
- Single (Participant)
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
- •Normal pregnancy
- •Scheduled caesarean section
- •Non-multiple pregnancy
- •Age of patient: 18 years and over
- •Height of patient: between 155 and 175 cm
- •Affiliated patients or beneficiaries of a Social Security System
- •Signature of the patient's consent
- •Exclusion criteria:
- •Patient <18 years
- •Pathological pregnancy
- •Multiple pregnancy
- •Emergency caesarean
- •Patients who cannot give informed consent (not French speaking)
- •Refusal of the patient
- •Contraindications to spinal anesthesia
- •Contraindications to Prilocaine
- •Contraindications to Bupivacaine
排除标准
- 未提供
研究组 & 干预措施
Hyperbaric Bupivacaine
spinal anesthesia for planned cesarean sections control group
干预措施: spinal anesthesia (Drug)
Hyperbaric Prilocaïne
spinal anesthesia for planned cesarean sections
干预措施: spinal anesthesia (Drug)
结局指标
主要结局
duration of motor block
时间窗: up to 6 hours
To compare the duration of motor block after spinal anesthesia with hyperbaric Prilocaïne versus hyperbaric Bupivacaine This evaluation is done every 15 min from the entrance to the recovery room (PACU); the motor block stops being evaluated when the modified bromination score reaches 4
次要结局
- The presence of post lumbar puncture syndrome(1 day)
- The upper sensory level(15 minutes after the LA injection)
- The time between injection and incision(1 day)
- The duration of the intervention(1 day)
- The presence of neuro-sensory disorders within 24 hours postoperatively(1 day)
- Statifaction of the Surgeon(1 day)
- The delay between spinal anesthesia and the first emergency analgesic injection(1 day)
- The time to return to the standard maternity ward(1 day)
- APGAR score of newborns at birth(1 day)
- score de satisfaction(1 day)
- Hypotensive episodes(1 day)
- Assessment of pain (VAS)(1 day)
- The delay between spinal anesthesia and the first injection of second-line analgesia(1 day)