Transmucular Quadratus Lumborum Block: Potential Quadriceps Muscle Weakness

NCT05023343 | Completed Phase 4 DMC

• 1 other identifier: SUH-TQL-QUADRICEPS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade

Keywords

Quadratus lumborum; Quadratus lumborum block; Ultrasound; Muscle weakness

Outcome Measures

Primary Outcomes (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.

  One hour

Secondary Outcomes (8)

• Single-leg 6 meter timed hop test

  One hour

• Timed Up and Go test

  One hour

• Dermatomal testing of thoracic and lumbar dermatomes

  One hour

• Dermatomal testing of thoracic and lumbar dermatomes

  One hour

• Dermatomal testing of thoracic and lumbar dermatomes

  One hour

Study Arms (2)

Active

ACTIVE COMPARATOR

Unilateral transmuscular quadratus lumborum block using 30 mL 0.75% ropivacaine

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

Placebo

PLACEBO COMPARATOR

Unilateral transmuscular quadratus lumborum block using 30 mL isotonic saline

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

Interventions

Ropivacaine DRUG

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

Active

Quadriceps muscle strength OTHER

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

Active; Placebo

Timed Up and Go OTHER

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

Active; Placebo

Single-leg 6 meter timed hop test OTHER

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

Active; Placebo

Temperature discrimination OTHER

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

Active; Placebo

Pinprick test OTHER

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

Active; Placebo

Blood samples DIAGNOSTIC_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

Active; Placebo

Non-invasive blood pressure measurement DIAGNOSTIC_TEST

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

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

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

Roskilde, Region Sjælland, 4000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38754991 DERIVED

MeSH Terms

Conditions

Muscle Weakness

Interventions

Ropivacaine; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Katrine Tanggaard, MD

  Zealand University Hospital, Department of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 26, 2021
• Study Start: October 2, 2021
• Primary Completion: November 28, 2021
• Study Completion: November 28, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)