Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Postoperative pain measured with VAS
研究概览
简要总结
Comparison of two types of analgesia after cesarean section.
All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).
详细描述
Written consent will be obtained before the cesarean section. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.
At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.25 % bupivacaine) on each side.
Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation.
Paracetamol, metamizol, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).
1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •obtained consent
- •singleton pregnancy
- •subarachnoid anaesthesia
排除标准
- •coagulopathy
- •allergy to to local anesthetics
- •depression, antidepressant drugs treatment
- •usage of painkiller before surgery
- •addiction to alcohol or recreational drugs
研究组 & 干预措施
TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
干预措施: TAP (transversus abdominis plane block) (Procedure)
TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
干预措施: Needle (Device)
TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
干预措施: Bupivacaine (Drug)
TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
干预措施: Paracetamol (Drug)
TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
干预措施: Metamizol (Drug)
TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
干预措施: Ketoprofen (Drug)
TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
干预措施: Morphine (Drug)
QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
干预措施: QL (quadratus lumborum block) (Procedure)
QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
干预措施: Bupivacaine (Drug)
QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
干预措施: Needle (Device)
QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
干预措施: Paracetamol (Drug)
QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
干预措施: Metamizol (Drug)
QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
干预措施: Ketoprofen (Drug)
QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
干预措施: Morphine (Drug)
结局指标
主要结局
Postoperative pain measured with VAS
时间窗: up to 24 hours after surgery
Acute pain measured with VAS (visual-analogue scale).
次要结局
- Neuropathic pain assessed with NPSI(6 months from the surgery)
研究者
Michał Borys
associate professor
Medical University of Lublin