跳至主要内容
临床试验/NCT05023343
NCT05023343已完成4 期

Does Administration of the Transmuscular Quadratus Lumborum Block Cause Quadriceps Muscle Weakness: A Randomised, Double-blinded Volunteer Study

Zealand University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年10月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Maximum unilateral knee extension strength

研究概览

简要总结

The aim of this study is to examine whether the administration of the TQL block cause motor block of the lumbar plexus and thereby quadriceps muscle weakness. The investigators hypothesise that the administration of a unilateral TQL block does not cause quadriceps muscle weakness compared to a placebo block.

详细描述

The ideal postoperative analgesic regimen following major abdominal and retroperitoneal laparoscopic surgery still lacks consensus and the discussion is ongoing. The epidural blockade has been the gold standard for postoperative pain management for major abdominal surgery for years, but with the conversion to minimal invasive surgery the procedure can rarely be justified.

The use of a multimodal analgesic regimen with opioids can cause severe side effects. These side effects can delay mobilisation after surgery, increase the risk of complications and worst of all be fatal.

The focus on an opioid sparing regimen, in the enhanced recovery setting, has been a significant motivator for the addition of ultrasound-guided nerve blocks to the perioperative progression.

At the Department of Anaesthesiology, Zealand University Hospital, the ultrasound-guided Transmuscular Quadratus Lumborum (TQL) block is part of the perioperative pain regimen for major laparoscopic abdominal and retroperitoneal surgeries, as well as for elective caesarean sections. Using the visual guidance of ultrasound, the injectate of local anaesthetic is administered in the fascial interspace between the quadratus lumborum muscle and the psoas major muscle posterior to the transversalis fascia.

This will anaesthetise the abdominal wall including both somatic and visceral nerves. No involvement of lumbar plexus i.e. the femoral nerve, obturator nerve or the lumbar part of the sympathetic trunk was observed. The lack of lumbar plexus involvement means no motor block of the lower extremities should be observed. Previous clinical studies reported no adverse events. However, the investigators did not specifically register lower limb weakness or hypotension, but on the other hand did not find any difference in ambulation or even faster ambulation compared to the placebo group.

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
Quadruple (Participant, Care Provider, Investigator, 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

入选标准

  • Age ≥ 18 years
  • American Associations of Anaesthesiologist (ASA) class 1-2
  • Have received written and oral information and signed the consent form
  • Weight > 56,5 kilograms (Chosen due to maximum single dose of ropivacaine i.e. 225 milligrams)

排除标准

  • Inability to speak and understand Danish
  • Inability to cooperate
  • Allergy to study drugs
  • Daily intake of opioids
  • Alcohol and/or drug overuse
  • Fertile female participants: No use of safe contraceptives for the last month, positive urine-HCG or breastfeeding
  • Previous trauma of surgery in the abdomen, hip or knee.
  • Any systemic muscular or neuromuscular disease

研究组 & 干预措施

Active

Active Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

干预措施: Blood samples (Diagnostic Test)

Active

Active Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

干预措施: Ropivacaine (Drug)

Active

Active Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

干预措施: Quadriceps muscle strength (Other)

Active

Active Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

干预措施: Timed Up and Go (Other)

Active

Active Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

干预措施: Single-leg 6 meter timed hop test (Other)

Active

Active Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

干预措施: Temperature discrimination (Other)

Active

Active Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

干预措施: Pinprick test (Other)

Active

Active Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

干预措施: Non-invasive blood pressure measurement (Diagnostic Test)

Placebo

Placebo Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline

干预措施: Quadriceps muscle strength (Other)

Placebo

Placebo Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline

干预措施: Timed Up and Go (Other)

Placebo

Placebo Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline

干预措施: Single-leg 6 meter timed hop test (Other)

Placebo

Placebo Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline

干预措施: Temperature discrimination (Other)

Placebo

Placebo Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline

干预措施: Pinprick test (Other)

Placebo

Placebo Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline

干预措施: Blood samples (Diagnostic Test)

Placebo

Placebo Comparator

Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline

干预措施: Non-invasive blood pressure measurement (Diagnostic Test)

结局指标

主要结局

Maximum unilateral knee extension strength

时间窗: One hour

The change in maximum, unilateral knee extension strength (newtonmeters (Nm)) comparing active and placebo TQL block, measured as the change from baseline to one hour after block administration.

次要结局

  • Adverse events(At least 2 hours post block administration)
  • Total ropivacaine serum concentration(One hour)
  • Single-leg 6 meter timed hop test(One hour)
  • Dermatomal testing of thoracic and lumbar dermatomes(One hour)
  • Timed Up and Go test(One hour)
  • Non-invasive blood pressure (Mean arterial pressure)(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验