跳至主要内容
临床试验/NCT03879980
NCT03879980已完成不适用

Effect of Preincisional Ultrasound-guided Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Transperitoneal Laparoscopic Nephrectomy: A Single-Blinded, Randomised Control Trial

Indonesia University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年3月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Intraoperative fentanyl consumption

研究概览

简要总结

Quadratus lumborum (QL) block can reduce intraoperative opioid consumption, decrease inflammation responses of IL-6, and reduce acute pain intensity in comparison with non-receiving QL block as the control group.

详细描述

Quadratus lumborum block had been studied as an effective postoperative analgesia in lower abdominal surgery, due to its spread to the thoracic paravertebral space and thoracolumbar fascia nerve. The effect of preincisional ultrasound (US)-guided QL block as "preemptive analgesia" on patient underwent laparoscopic living donor nephrectomy has never been evaluated. As preemptive analgesia, quadratus lumborum block could provide analgesics before and after surgery. Both groups immediately received basic postoperative analgesia regimen paracetamol 1 gr IV 8th hourly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

Forty-four healthy patients with American Society of Anesthesiologists (ASA) classification I or II gave written consent to participate and were randomly allocated into QL block group or control (non-QL block) group. Randomisation used blocks of 4 into 2 groups using a list of random numbers and was performed by sealed envelopes. The surgeries were performed by 3 urology surgeon consultants with comparable distributions. Patients and principal investigator were blinded to group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI < 30 kg/m2
  • ASA 1 or 2

排除标准

  • refused to participate
  • chronic use of analgesics or anti-inflammatory drugs
  • allergy to local anaesthetic
  • duration of surgery <4 or > 6 hours
  • duration of anaesthesia <5 or > 7 hours
  • neuropathy

研究组 & 干预措施

Non-QL block

Placebo Comparator

The control (non-QL block) group only received fentanyl IV during surgery.

干预措施: Non-QL block (Drug)

Bilateral QL block

Experimental

The patients were in the semi-lateral supine position to show up the side to be blocked. Using USG and 1-6 MHz convex transducer placed in the transverse plane above the iliac crest at the level of the umbilicus. A Stimuplex® 20G 100-mm needle was advanced in anteroposterior direction toward the junction of tapered abdominal muscle layer and QL muscle, and 20 ml of 0.25% bupivacaine was deposited in the anterolateral border of QL muscle at the junction with the transversalis fascia reach outside the anterior layer of transversalis fascia. The lateral approach QL (type I) blocks were performed at both sides of patients. The total amount of bupivacaine was 100 mg for each patient

干预措施: Bilateral QL block (Drug)

结局指标

主要结局

Intraoperative fentanyl consumption

时间窗: Intraoperative

Intraoperative fentanyl consumption was recorded as total consumption in µg, and calculated into mean consumption per hour in µg.kg-1.h-1, due to the influence of patients body weight and duration of surgery to the given dose of fentanyl boluses.

Changes in Interleukin-6 from baseline

时间窗: 24 hours

Measurement of plasma Interleukin-6 before the anaesthesia induction as the baseline; 2 hours of surgical stimulation and gas insufflation intraoperatively; and 2 hours after recovery from anaesthesia.

次要结局

  • Numerical Rating Scale(24 hours)
  • Hemodynamic Profiles: Heart Rate in bpm(Intraoperative)
  • Hemodynamic Profiles: Systolic, Diastolic, and Mean Arterial Pressure in mmHg(Intraoperative)
  • Number of participants with additional intravenous tramadol(24 hours)
  • Number of participants with additional intravenous fentanyl(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dita Aditianingsih

Principal Investigator, Head of Intensive Care Unit, Anesthesiologist Consultant

Indonesia University

研究点 (1)

Loading locations...

相似试验