Ultrasound Guided Transversus Abdominalis Plane Block ( TAPB) Versus Quadratus Lumborum Type II Block (QLBII) in Perioperative Analgesia for Kidney Transplantation Procedure: Clinical Randomized Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Total postoperative fentanyl usage
研究概览
简要总结
The main advantage of Quadratus Lumborum Block (QLB) compared to Transversus Abdominalis Plane Block (TAPB) is the impact on visceral pain due to the spread of the local anaesthetic agent to the paravertebral space. It may produce extensive analgesia and better pain control.
Previews studies shoved the effectiveness of TAPB in kidney transplantation procedure (KTX) by reducing opioids requirements during and after the operation. QLB was not evaluating in KTX procedure yet, but it reduced postoperative morphine requirement after cesarean section under spinal anaesthesia.
The aim of this prospective, randomised controlled, multicenter, clinical study is to compare the perioperative analgesic efficacy of QLB and TAPB in patients who had KTX under balanced (general and regional) anaesthesia.
详细描述
After Bioethical Committee of Medical University of Warsaw approval, informed written consent will be obtained from all patients.
A sample size of 104 patients was calculated to obtain at list 25% reduction of fentanyl usage in QLBII group with 0,05% significance and power of 0,8. Consenting patients, scheduled to KTX procedure under general anaesthesia will be randomly assigned (1:1) according to the computer -generated randomization list with permuted blocks (block sizes: 20, 20, 24, 40) to receive 20ml of 0,25% Bupivacaine with epinephrine ipsilaterally to the operation side in QLBII or TAPB after the general anaesthesia induction and before the surgery starts. All the blocks will be performed in the supine patients position, under ultrasound guidance for both techniques. The correct spread of injectate will be confirmed with ultrasound.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplantation procedure with anatomical urinary outlet
- •Written informed consent
排除标准
- •Patients' refusal
- •Known allergies to study medication
- •Inability to comprehend or participate in pain scoring scale
- •Inability to use intravenous patient controlled analgesia system
- •Anatomic, posttraumatic and postoperative deformations could possibly affect the spread of local anesthetic in transversus abdominalis plane or quadratus lumborum muscle plane.
- •Transversus abdominalis plane or quadratus lumborum muscle plane not seen in ultrasound examination.
研究组 & 干预措施
Quadratus Lumborum Block type II
Unilateral ultrasound guidance QLB on the operated side after induction of general anaesthesia - 20 ml of 0,25%bupivacaine with adrenaline injected with ultraplex needle
干预措施: Bupivacaine (Drug)
Quadratus Lumborum Block type II
Unilateral ultrasound guidance QLB on the operated side after induction of general anaesthesia - 20 ml of 0,25%bupivacaine with adrenaline injected with ultraplex needle
干预措施: Quadratus Lumborum Block type II (Procedure)
Quadratus Lumborum Block type II
Unilateral ultrasound guidance QLB on the operated side after induction of general anaesthesia - 20 ml of 0,25%bupivacaine with adrenaline injected with ultraplex needle
干预措施: Ultraplex (Device)
Transversus Abdominalis Plane Block
Unilateral ultrasound guidance TAPB on the operated side after induction of general anaesthesia - 20 ml of 0,25% bupivacaine with adrenaline injected with ultraplex needle
干预措施: Transversus Abdominalis Plane Block (Procedure)
Transversus Abdominalis Plane Block
Unilateral ultrasound guidance TAPB on the operated side after induction of general anaesthesia - 20 ml of 0,25% bupivacaine with adrenaline injected with ultraplex needle
干预措施: Bupivacaine (Drug)
Transversus Abdominalis Plane Block
Unilateral ultrasound guidance TAPB on the operated side after induction of general anaesthesia - 20 ml of 0,25% bupivacaine with adrenaline injected with ultraplex needle
干预措施: Ultraplex (Device)
结局指标
主要结局
Total postoperative fentanyl usage
时间窗: 24 hours
Total cumulative fentanyl dose used in the first 24 hours after surgery
次要结局
- Nausea or vomiting(24 hours)
- Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery(24 hours)
- Time to first analgesic (TTFA)(24 hours)
- Sedation Level(24 hours)
研究者
Marcin Kołacz
MD, PhD
Medical University of Warsaw