Transmuscular 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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005382-14-DK

Enrollment

Registered

2021-01-12

Start date

2021-08-16

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Healthy volunteers (to investigate potential quadriceps muscle weakness following administration of a Transmuscular Quadratus Lumborum block) MedDRA version: 23.1 Level: LLT Classification code 10068084 Term: Anesthesia procedure System Organ Class: 100000004865

Interventions

Trade Name: Ropivacain Pharmaceutical Form: Injection INN or Proposed INN: Ropivacain Other descriptive name: ROPIVACAINE HYDROCHLORIDE Concentration unit: % percent Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - American Associations of Anaesthesiologist (ASA) class 1-2 - Have received written and oral information and siged the consent form - Weight > 56,5 kilograms (Chosen due to maximum single dose of ropivacaine ie. 225 milligrams). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

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 urin-HCG or breastfeeding - Previous trauma of surgery in the abdomen, hip or knee. - Any systemic muscular or neuromuscular disease

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. We hypothesise that the administration of a unilateral TQL block does not cause quadriceps muscle weakness compared to a placebo block. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome in this study is 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.;Timepoint(s) of evaluation of this end point: Baseline (before block administration) and 60 minutes following block administration	—

Measure

Time frame

Main Objective: 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. We hypothesise that the administration of a unilateral TQL block does not cause quadriceps muscle weakness compared to a placebo block. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome in this study is 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.;Timepoint(s) of evaluation of this end point: Baseline (before block administration) and 60 minutes following block administration

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Secondary

Measure	Time frame
Secondary end point(s): - 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. - Change in Timed Up and Go test (minutes, standardised protocol) - Dermatomal spread of the TQL block using standardised mechanical (pinprick) and temperature (cold and warmth) discrimination (number of dermatomes). - Change in non-invasive blood pressure from baseline to T30min - Total concentration of ropivacaine at 0, 15, 30, 45 and 60 minutes following administration of the unilateral TQL block. - Number of adverse events (Using ‘Summary of Product Characteristics’ as a guideline) ;Timepoint(s) of evaluation of this end point: Physiological tests and dermatomal spread is evaluated 60 minutes after block administration. Physiological tests are compared to baseline. Blood samples are collected 0, 15, 30, 45 and 60 minutes after block administration. Adverse events are evaluated during the entire study (approximately 4 hours per participant)	—

Measure

Time frame

Secondary end point(s): - 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. - Change in Timed Up and Go test (minutes, standardised protocol) - Dermatomal spread of the TQL block using standardised mechanical (pinprick) and temperature (cold and warmth) discrimination (number of dermatomes). - Change in non-invasive blood pressure from baseline to T30min - Total concentration of ropivacaine at 0, 15, 30, 45 and 60 minutes following administration of the unilateral TQL block. - Number of adverse events (Using ‘Summary of Product Characteristics’ as a guideline) ;Timepoint(s) of evaluation of this end point: Physiological tests and dermatomal spread is evaluated 60 minutes after block administration. Physiological tests are compared to baseline. Blood samples are collected 0, 15, 30, 45 and 60 minutes after block administration. Adverse events are evaluated during the entire study (approximately 4 hours per participant)

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Countries

Denmark

Contacts

Public ContactJens Børglum

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

jedn@regionsjaelland.dk4530700120

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026