Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Postoperative pain measured with VAS
研究概览
简要总结
All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total morphine consumption and time to the first demand will be noted. 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.
All patients will receive PCA (patient controlled analgesia) pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit). In PACU vital signs will be monitored.
Each patient will be randomly assigned to one of three groups. In the first group of patients no additional regional analgesia will be performed. In the second and the third group, ultrasound-guided transversus abdominis plane or quadratus lumborum block will be done with 0.375 % ropivacaine (0.2 ml per kg 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.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, care providers, and assessors were not aware of type of the block
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 morphine and local anesthetics
- •depression, antidepressant drugs treatment
- •usage of painkiller before surgery
- •addiction to alcohol or recreational drugs
研究组 & 干预措施
PCA
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
干预措施: Paracetamol (Drug)
PCA
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
干预措施: subarachnoid anesthesia (Procedure)
PCA
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
干预措施: PCA (patient controlled analgesia) (Procedure)
PCA
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
干预措施: Metamizol (Drug)
PCA
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
干预措施: Ketoprofen (Drug)
PCA
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
干预措施: Bupivacaine (Drug)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: TAP (transversus abdominis plane block) (Procedure)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Stimuplex Ultra 360 needle (Device)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Ropivacaine (Drug)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Paracetamol (Drug)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: subarachnoid anesthesia (Procedure)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: PCA (patient controlled analgesia) (Procedure)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Metamizol (Drug)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Ketoprofen (Drug)
TAP
Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Bupivacaine (Drug)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: QLB (quadratus lumborum block) (Procedure)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Stimuplex Ultra 360 needle (Device)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Ropivacaine (Drug)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Paracetamol (Drug)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: subarachnoid anesthesia (Procedure)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: PCA (patient controlled analgesia) (Procedure)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Metamizol (Drug)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Ketoprofen (Drug)
QLB
Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section.
PCA with morphine in the PACU
干预措施: Bupivacaine (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)
- Morphine consumption(up to 24 hours after surgery)
研究者
Michał Borys
associate professor
Medical University of Lublin