Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 主要终点
- Postoperative standing pain at day 2
研究概览
简要总结
Analgesia following surgery associates different intra-venous or oral analgesic drugs and sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be administered as a complement. In the specific context of caesarean sections, pain control is mandatory to enable the mother to take care of her offspring and shorten their hospital stay. This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural), enabling the injection of morphine in the subdural or epidural space, as part of a multimodal analgesia regimen.
Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce postoperative morphine consumption. Recent studies have compared the two techniques and found conflicting results. Furthermore, they did not consider caesarean section performed under epidural analgesia, with a different neuraxial injection site, neither did they compared pain after postoperative day 2.
Consequently, the aim of this study was to compare resting and standing pain up to postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous infiltration provided a better analgesia at day 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
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
- •Informed consent,
- •Age>/=18 years,
- •Caesarean section under spinal or epidural anaesthesia
- •Technique surgical "Cohen Stark méthod".
排除标准
- •Patient refusal,
- •Patient under guardianship,
- •Contraindication to one of the two techniques,
- •Cesarean section under general anesthesia
- •Allergies to local anesthetics
- •Maternal instability
研究组 & 干预措施
Spinal-anesthesia
Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
干预措施: USG-TAP block (Drug)
Spinal-anesthesia
Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC
干预措施: CIC (Drug)
Epidural-anesthesia
Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
干预措施: USG-TAP block (Drug)
Epidural-anesthesia
Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC
干预措施: CIC (Drug)
结局指标
主要结局
Postoperative standing pain at day 2
时间窗: Evaluate standing pain at 48 hours postoperatively
Assessment of Pain on Mobilization by a Numeric Scale of Pain
次要结局
- Cumulative dose of nefopam during the first 3 days(during the first 3 days)
- patient comfort assessed daily by visual analogic scale(during the first 3 days)
- standing and resting pain measured during the first 3 days(Evaluate pain at during 3 days postoperatively)
- Cumulative dose of Tramadol during the first 3 days(during the first 3 days)
- Cumulative dose of oxycodone during the first 3 days(during the first 3 days)