Ultrasound Guided 0.25% Ropivacaine Transversus Abdominis Plane Block in Addition to Intrathecal Morphine and Multimodal Analgesia for the Management of Postoperative Pain Among Women Undergoing Cesarean Delivery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period.
研究概览
简要总结
This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-emergent CD with planned spinal anesthesia
- •American Society of Anesthesia physical status class I & II
- •Age ≥ 18 years
- •Term gestational age (≥ 37 weeks)
- •English-speaking
排除标准
- •Morbid Obesity (BMI³ 45 kg/m2)
- •Laboring women
- •Emergency CD
- •Severe maternal cardiac disease
- •Subjects with significant obstetric co-morbidities
- •Failed spinal anesthesia
- •Patient enrollment in another study involving medication within 30 days of CD
- •Any other condition which may impair ability to cooperate with data collection
- •Height less than 152 cm (5'0")
- •Fetal anomalies or intrauterine fetal death
研究组 & 干预措施
0.25% Ropivicaine
0.25% ropivicaine (maximum 1.5mg/kg)
干预措施: Ropivicaine (Drug)
Placebo
20ml saline
干预措施: Saline placebo (Drug)
结局指标
主要结局
The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period.
时间窗: 24 hours
次要结局
- NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation(48 hours)
- TAP block success rates and duration of block effect will be assessed using a patient diary completed every 2 hours while the patient is awake.(24 hours)
- Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.(6 months)
研究者
Ronald George
Primary Investigator, MD, FRCPC, Assistant Professor
IWK Health Centre