Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
Ultrasound-guided Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section: a Double-blind Randomized Controlled Clinical Trial
研究概览
详细说明
Transversus abdominis plane block (TAPB) is a regional anesthetic technique that can provide analgesia for lower abdominal surgical procedures. Previous meta-analyses and recently published clinical trials have demonstrated promising results for this technique when it is used as part of multimodal postoperative pain treatment, but no consensus exists regarding the potency of this type of anesthetic procedure for analgesia after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery. In this study, the correct execution of an USG-TAPB was verified, and then the procedure was matched with the obtained analgesic effect after a CS.
The secondary aims were to determine whether USG-TAPB could ensure a decline in postoperative requests for opiates and fewer opiate-related side effects, the return of faster bowel function, and shorter recovery time without generating critical hemodynamic changes.
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-III
- Caesarian Section. The Pfannenstiel incision was performed.
Exclusion Criteria:
- body mass index (BMI) >35
- allergy to local anesthetics
- skeletal and/or muscle abnormalities of the spine
- primary and/or secondary neurological diseases
- psychiatric diseases
- history of chronic pain and/or neuropathic disorders
- history of drug abuse
- state of sepsis
- infection and/or tumors within the skin on the back
- primary or secondary coagulopathies
- pre-eclampsia or eclampsia.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Levobupivacaine 100 mg, USG TAP Block
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
|
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
其他名称：
|
|
安慰剂比较：Placebo
20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery
|
20 ml of saline saline by intramuscular injection, at the end of surgery
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery
大体时间：72 hours
|
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
|
72 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient satisfaction at 72 hours from surgery
大体时间：72 hours
|
Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied)
|
72 hours
|
|
The time of recovery of bowel function at 72 hours from surgery
大体时间：72 hours
|
Time (in hours) to have defacation
|
72 hours
|
|
The time of hospital discharge at 72 hours after surgery
大体时间：72 hours
|
Time (days after surgery) for hospital discharging
|
72 hours
|
|
The consumption of painkillers at 72 hours after surgery
大体时间：72 hours
|
The equianalgesic dose (in mg) of morphine.
|
72 hours
|
|
The healing of the surgical wound at 72 hours
大体时间：72 hours
|
Descriptive scale of four step: unacceptable/acceptable/excellent healing
|
72 hours
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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