Transversus Abdominis Plane Block With Intrathecal Fentanyl Versus Intrathecal Morphine in Cesarean Delivery: A Randomized, Controlled, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain score with movement at 24 hours after delivery
研究概览
简要总结
This noninferiority study aims to determine whether transversus abdominis plane (TAP) block with intrathecal fentanyl could provide a noninferior analgesia compared with intrathecal morphine after cesarean delivery under spinal anesthesia.
详细描述
Healthy mothers scheduled to undergo elective cesarean delivery under spinal anesthesia will be randomly allocated to receive either TAP block plus intrathecal fentanyl (Group TF) or intrathecal morphine (Group M).
Primary outcome is pain score with movement at postoperative 24 hours.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult full-term parturients scheduled to undergo elective cesarean delivery under spinal anesthesia
排除标准
- •Contraindication to spinal anesthesia
- •Any chronic pain unrelated pregnancy
- •current opioid medication use
- •BMI more than 40 kg m-2
- •History of drug allergy or hypersensitivity to fentanyl, morphine, ropivacaine, acetaminophen, NSAIDs, bupivacaine, ramosetron, ondansetron, nalbuphine, Naloxone, metoclopramide
- •infection of abdominal wall
- •Pregnancy-induced hypertension
- •known cardiovascular disease
- •Known fetal anomaly
- •Any sign of onset of labor
研究组 & 干预措施
Transversus abdominis plane block and intrathecal fentanyl
Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + fentanyl 10 mcg. Following the completion of surgery, ultrasound-guided bilateral transversus abdominis plane block will be done with 0.375% ropivacaine 15 ml per each side.
干预措施: fentanyl (Drug)
Transversus abdominis plane block and intrathecal fentanyl
Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + fentanyl 10 mcg. Following the completion of surgery, ultrasound-guided bilateral transversus abdominis plane block will be done with 0.375% ropivacaine 15 ml per each side.
干预措施: Transversus abdominis plane block (Procedure)
Intrathecal morphine
Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + morphine 75 mcg. Following the completion of surgery, sham block will be done using normal saline.
干预措施: morphine (Drug)
Intrathecal morphine
Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + morphine 75 mcg. Following the completion of surgery, sham block will be done using normal saline.
干预措施: Sham block (Procedure)
结局指标
主要结局
Pain score with movement at 24 hours after delivery
时间窗: at 24 hours after delivery
Pain score with movement at 24hr after delivery, using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable)
次要结局
- Intravenous fentanyl consumption(at 6, 12, 18, 24, 48 hours after delivery)
- Nausea severity(During the first 48 hour-period after delivery)
- Pain score at rest(at 6, 12, 18, 24, 48 hours after delivery)
- Pain score with movement(at 6, 12, 18, 48 hours after delivery)
- time to first opioid request(during hospital stay, an average of 3 days)
- number of patients requiring rescue analgesics(During the first 48 hour-period after delivery)
- Incidence of nausea(During the first 48 hour-period after delivery)
- Incidence of vomiting(During the first 48 hour-period after delivery)
- Pruritus severity(During the first 48 hour-period after delivery)
- Patient satisfaction for overall postoperative managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied)(During the first 48 hour-period after delivery)
- Incidence of pruritus(During the first 48 hour-period after delivery)
- Incidence of sedation(During the first 48 hour-period after delivery)
- Incidence of respiratory depression(During the first 48 hour-period after delivery)
- Hospital length of stay(From admission to hospital discharge, an average of 3 days)
- Apgar Score(at 1 minute, at 5 minutes)
- Umbilical arterial pH(immediately after delivery)
- Umbilical arterial PO2(immediately after delivery)
- Umbilical arterial PCO2(immediately after delivery)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital