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Transmucular Quadratus Lumborum Block: Potential Quadriceps Muscle Weakness

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05023343
Enrollment
20
Registered
2021-08-26
Start date
2021-10-02
Completion date
2021-11-28
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

Quadratus lumborum, Quadratus lumborum block, Ultrasound, Muscle weakness

Brief summary

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.

Detailed description

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. A few case reports have reported complications related to the various quadratus lumborum blocks. Ueshima et al. reported that 90% (65/81 cases) experienced quadriceps muscle weakness following a TQL block. The incidence was 19% for posterior QL block and 1% for lateral QL block. Lower limb weakness was also reported by Wikner et al. following a bilateral lateral QL block. A case of continuous hypotension after administration of a lateral QL block has been described. One case of unilateral upper limb weakness and Horners Syndrome after a bilateral posterior QL block has also been reported. Urinary retention was reported following a continuous TQL-block. All side effects were temporary, no one reported permanent injuries. Complications have not been reported systematically. At Zealand University Hospital, Roskilde, the investigators have administrated more than 1000 TQL blocks, and more than 300 patients have been included in various clinical trials. From clinical experience and cadaveric studies, the investigators find no evidence that the TQL block spread to the epidural space, and therefore does not cause sympathetic symptoms. Neither does the TQL block spread to the lumbar plexus, and therefore does not cause motor weakness of the lower extremities. However these notions have never been properly investigated in a controlled clinical setting, meaning that the investigators cannot entirely rule out the possibility of a spread to the lumbar plexus and thus ensuing quadriceps muscle weakness. This calls for a more in-depth investigation of this potential phenomenon. Therefore, 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. Prior to block administration all participants are tested using the same motor tests as after the block administration(baseline tests). All participants will receive two TQL blocks. To keep participants and outcome assessors blinded the study drug for each side will be randomised i.e. active treatment on one side and placebo on the contralateral side. The investigators hypothesise that the administration of a unilateral TQL block does not cause quadriceps muscle weakness compared to a placebo block. Sub-study: Fascial plane nerve blocks demand a great volume of local anaesthetic to achieve the right spread of local anaesthetic and thus a sufficient analgesia. The correct concentration and volume of local anaesthetic is still debated. Studies measuring serum concentrations of local anaesthetic are rare due to time consumption and high costs. When administering a unilateral TQL block a volume of 30 ml local anaesthetic is used often equal to the maximum single-shot dose of ropivacaine; i.e. 225 milligrams. In previous studies and in the usual clinical setting the investigators have never experienced any signs of systemic toxicity, however the maximum serum concentration of local anaesthetic following TQL block administration has never been investigated. The maximum serum ropivacaine concentration following administration of a TQL block will therefore be investigated for all participants.

Interventions

DRUGRopivacaine

30 mL Ropivacaine 0,75% administered as a unilateral TQL block

Quadriceps muscle strength is assessed using a hand-held dynamometer. Each participant is tested pre block administration and 60 minutes after

To test mobilisation the standardised Timed Up and Go test is used. Each participant is tested pre block administration and 60 minutes after

OTHERSingle-leg 6 meter timed hop test

To test muscle strength and power the single-leg 6 meter jump test is used. Each participant is tested pre block administration and 60 minutes after

OTHERTemperature discrimination

Dermatomal evaluation of cold and warm discrimination of the thoracic and lumbar dermatomes Approximately 60 minutes after block administration

Dermatomal evaluation of pinprick/sharp sensation of the thoracic and lumbar dermatomes. Approximately 60 minutes after block administration

DIAGNOSTIC_TESTBlood samples

As a substudy the maximum serum concentration of ropivacaine is analyzed. Blood samples are taken at 0, 15, 30, 45 and 60 minutes after block administration

Non-invasive blood pressure is measured prior to block administration and 30 minutes after block administration

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Each participant serves as their own control i.e. each participant will receive both an active and placebo block TQL block. Left/right side are randomized.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Maximum unilateral knee extension strengthOne hourThe 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.

Secondary

MeasureTime frameDescription
Timed Up and Go testOne hourChange in Timed Up and Go test (minutes, standardised protocol) from baseline to one hour after block administration
Dermatomal testing of thoracic and lumbar dermatomesOne hourDermatomal spread of the TQL block using standardised mechanical (pinprick) discrimination (number of dermatomes)
Single-leg 6 meter timed hop testOne hourChange in time performing the single-leg 6 meter timed hop test (Minutes, standardised protocol) comparing active and placebo TQL block, measured as the change from baseline to one hour after block administration.
Adverse eventsAt least 2 hours post block administrationNumber of adverse events
Total ropivacaine serum concentrationOne hourTotal concentration of ropivacaine at 0, 15, 30, 45 and 60 minutes following administration of the unilateral TQL block.
Non-invasive blood pressure (Mean arterial pressure)30 minutesChange in non-invasive blood mean arterial pressure from baseline to T30min (mmH

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026