Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Post operative Pain
研究概览
简要总结
The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital.
详细描述
Randomized clinical trial of Transversus Abdominis Plane Block (TAP block) at Cesarean Section.
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
- Double (Participant, 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
- •ASA status II to III
- •All patients undergoing elective CS under regional anesthesia at any gestational age.
排除标准
- •- Known drug allergy to local anesthetics
- •Planned general anesthetic
- •NSAID use contraindicated post partum
- •Chronic pain disorder or chronic narcotic use/dependence
- •Planned vertical abdominal incision
- •Planned Cesarean Hysterectomy.
- •Placenta Previa or suspected Placenta Accreta
研究组 & 干预措施
No TAP block
A sham procedure will not be performed but the patient will be unaware of whether or not an injection was done.
Surgeon-administered Transversus Abdominis Plane Block (TAP block)
After uterine closure, the anterior abdominal wall on the contralateral side to the surgeon is elevated and retracted laterally by an assistant. The bowel and uterus is retracted using the surgeon's non-dominant hand, with or without a sponge. Under direct visualization, a blunted spinal needle is inserted lateral to the rectus muscle to avoid injury to inferior epigastric blood vessels. The needle is then gently advanced through the transversus abdominis fascia into the TAP plane, identified at loss of resistance, or 'a pop'. After aspiration to confirm no accidental placement of the needle intravascularly, local anaesthetic is infiltrated into the transverse abdominis plane through the parietal peritoneum by the surgeon at a prespecified dose of 0.25% bupivicaine 0.25 mL/kg (approximately 20cc). This is repeated on the contralateral side, after which closure of the fascia, subcutaneous tissue, and skin were performed.
干预措施: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg (Other)
结局指标
主要结局
Post operative Pain
时间窗: 12 hours post op
VAS scale 0-no pain to 10-worst pain
次要结局
- Time to first request for rescue analgesia in hours(48 hours post op)
- Time from surgery to discharge from hospital(Up to discharge from hospital, usually 1-3 days)
- Post operative Opioid use(up to 48 hours post op.)
研究者
Stephen Wood
Dr Stephen Wood
University of Calgary