Ultrasound-guided Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section: a Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 96
- 主要终点
- Postoperative pain (Numeric Rate Scale) at 72 hours after surgery
研究概览
简要总结
In many countries, caesarean section (CS) rates have been increasing. The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method of performing this block has been matched with the obtained analgesic effect 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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Caesarian Section. The Pfannenstiel incision was performed.
排除标准
- •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.
研究组 & 干预措施
Levobupivacaine 100 mg, USG TAP Block
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
干预措施: Levobupivacaine (Drug)
Placebo
20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery
干预措施: Saline (Drug)
结局指标
主要结局
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery
时间窗: 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").
次要结局
- Patient satisfaction at 72 hours from surgery(72 hours)
- The consumption of painkillers at 72 hours after surgery(72 hours)
- The time of recovery of bowel function at 72 hours from surgery(72 hours)
- The time of hospital discharge at 72 hours after surgery(72 hours)
- The healing of the surgical wound at 72 hours(72 hours)
研究者
Emiliano Petrucci
Anesthesist
San Salvatore Hospital of L'Aquila