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Neuromuscular BlockadePhase 4NCT05023343

Transmucular Quadratus Lumborum Block: Potential Quadriceps Muscle Weakness

A Phase 4 study testing Ropivacaine, Quadriceps muscle strength and Timed Up and Go in people with Neuromuscular Blockade, run by Zealand University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Neuromuscular Blockade
What is being tested?
Ropivacaine, Quadriceps muscle strength and Timed Up and Go
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteDenmark
Study dates
2 Oct 2021to 28 Nov 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Ropivacaine, Quadriceps muscle strength, Timed Up and Go, Single-leg 6 meter timed hop test, Temperature discrimination
Keywords
Quadratus lumborum, Quadratus lumborum block, Ultrasound, Muscle weakness
Medical subject headings
Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

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

  • Quadriceps muscle strengthOther

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

  • Timed Up and GoOther

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

  • Single-leg 6 meter timed hop testOther

    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

  • Temperature discriminationOther

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

  • Pinprick testOther

    Dermatomal evaluation of pinprick/sharp sensation of the thoracic and lumbar dermatomes.

    Approximately 60 minutes after block administration

  • Blood samplesDiagnostic test

    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 measurementDiagnostic test

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

Study groups in NCT05023343
Study groupRoleWhat they receive
ActiveActive comparatorUnilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine
Receives: Drug: Ropivacaine; Other: Quadriceps muscle strength; Other: Timed Up and Go; Other: Single-leg 6 meter timed hop test; Other: Temperature discrimination; Other: Pinprick test; Diagnostic Test: Blood samples; Diagnostic Test: Non-invasive blood pressure measurement
PlaceboPlacebo comparatorUnilateral transmuscular quadratus lumborum block using 30 mL isotonic saline
Receives: Other: Quadriceps muscle strength; Other: Timed Up and Go; Other: Single-leg 6 meter timed hop test; Other: Temperature discrimination; Other: Pinprick test; Diagnostic Test: Blood samples; Diagnostic Test: Non-invasive blood pressure measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum unilateral knee extension strength

    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.

    Measured: One hour

Secondary outcomes (8)
  1. Single-leg 6 meter timed hop test

    Change 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.

    Measured: One hour

  2. Timed Up and Go test

    Change in Timed Up and Go test (minutes, standardised protocol) from baseline to one hour after block administration

    Measured: One hour

  3. Dermatomal testing of thoracic and lumbar dermatomes

    Dermatomal spread of the TQL block using standardised mechanical (pinprick) discrimination (number of dermatomes)

    Measured: One hour

  4. Dermatomal testing of thoracic and lumbar dermatomes

    Dermatomal spread of the TQL block using standardised temperature (cold) discrimination (number of dermatomes).

    Measured: One hour

  5. Dermatomal testing of thoracic and lumbar dermatomes

    Dermatomal spread of the TQL block using standardised temperature (warmth/heat) discrimination (number of dermatomes).

    Measured: One hour

  6. Non-invasive blood pressure (Mean arterial pressure)

    Change in non-invasive blood mean arterial pressure from baseline to T30min (mmH

    Measured: 30 minutes

  7. Adverse events

    Number of adverse events

    Measured: At least 2 hours post block administration

  8. Total ropivacaine serum concentration

    Total concentration of ropivacaine at 0, 15, 30, 45 and 60 minutes following administration of the unilateral TQL block.

    Measured: One hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2021
  2. Study start2 Oct 2021
  3. Primary completion28 Nov 2021
  4. Study completion28 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05023343
Sponsor's protocol ID
SUH-TQL-QUADRICEPS
Status last verified
Dec 2021
First submitted
17 Aug 2021
Last updated
21 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tanggaard K, Nielsen MV, Holm UHU, Hoffmann BM, Bernhoff C, Andersen CH, Thomassen SS, Hansen C, Dam M, Poulsen TD, Holm PM, Borglum J. No quadriceps muscle weakness following anterior quadratus lumborum block compared with placebo: a randomized, non-inferiority, blinded, volunteer trial. Reg Anesth Pain Med. 2025 Jul 4;50(7):568-574. doi: 10.1136/rapm-2024-105313.

    PubMed 38754991

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine, Quadriceps muscle strength and Timed Up and Go in people with Neuromuscular Blockade, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum unilateral knee extension strength (time frame: One hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05023343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.

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