Does Administration of the Transmuscular Quadratus Lumborum Block Cause Quadriceps Muscle Weakness: A Randomised, Double-blinded Volunteer Study
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
- 是
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
Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
干预措施: Blood samples (Diagnostic Test)
Active
Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
干预措施: Ropivacaine (Drug)
Active
Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
干预措施: Quadriceps muscle strength (Other)
Active
Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
干预措施: Timed Up and Go (Other)
Active
Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
干预措施: Single-leg 6 meter timed hop test (Other)
Active
Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
干预措施: Temperature discrimination (Other)
Active
Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
干预措施: Pinprick test (Other)
Active
Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
干预措施: Non-invasive blood pressure measurement (Diagnostic Test)
Placebo
Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline
干预措施: Quadriceps muscle strength (Other)
Placebo
Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline
干预措施: Timed Up and Go (Other)
Placebo
Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline
干预措施: Single-leg 6 meter timed hop test (Other)
Placebo
Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline
干预措施: Temperature discrimination (Other)
Placebo
Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline
干预措施: Pinprick test (Other)
Placebo
Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline
干预措施: Blood samples (Diagnostic Test)
Placebo
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)
