Combined Transversalis Fascia and Transversus Abdominis Plane Blocks Versus Intrathecal Morphine: Effects on Postoperative Opioid Consumption and Obstetric Recovery After Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Obstetric Quality of Recovery-10 (ObsQoR-10) Score
研究概览
简要总结
Cesarean delivery rates are rising globally, and effective postoperative analgesia is crucial for maternal recovery and newborn care. While intrathecal morphine offers strong analgesia, it may cause side effects such as nausea, pruritus, or respiratory depression. The transversus abdominis plane (TAP) block provides somatic pain relief but is often insufficient alone. The transversalis fascia plane block (TFPB) has been shown to enhance lower abdominal analgesia. This study aims to evaluate whether combining TAP and TFP blocks can provide analgesic efficacy comparable to intrathecal morphine in cesarean section patients who are unable to receive opioids or are at high risk of side effects.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-45 years old
- •American Society of Anesthesiologists physical score I or II
- •caesarean section with a Pfannenstiel incision
排除标准
- •additional surgical intervention, or received general anaesthesia,
- •hypersensitivity to the agents to be used
- •BMI greater than 35 kg m-2
- •coagulopathy,
- •local infection,
- •opioid addiction,
- •pregnancy-related hypertension
- •diabetes mellitus
研究组 & 干预措施
Intrathecal Morphine
干预措施: Intrathecal Morphine (Procedure)
Transversalis fascia+Transversus abominis plane block
干预措施: Transversalis fascia plane block and transversus abdominis plane block (Procedure)
结局指标
主要结局
The Obstetric Quality of Recovery-10 (ObsQoR-10) Score
时间窗: Postoperative 24 hours
The questionnaire's subscales are physical comfort (n=3 items), emotional state (n=2 items), pain (n=1 item), physical independence (n=2 items), and the ability to take care of the newborn (n=2 items). Each item is scored on a scale of 0-10, except for the first four items, which are graduated from 10 to 0. The total score is the sum of all item scores (i.e. a score ranging from 0 to 100, where 0 is the worst recovery score, and 100 indicates the best).
次要结局
- Opioid consumption(Postoperative 24. hours)
研究者
Ali Ahiskalioglu
Principal Investigator
Ataturk University