The Effect of Local Anesthetic Volume within the Adductor Canal on Quadriceps Function Evaluated by Electromyography: A Randomized, Observer-Masked, Placebo-Controlled Study in Volunteers.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004601-32-DK

Enrollment

Unknown

Registered

2014-10-29

Start date

2015-01-07

Completion date

Unknown

Last updated

2016-08-16

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

Conditions

Healthy volunteers. Results will be used for optimizing the treatment of post-operative pain after total knee arthroplasty MedDRA version: 17.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Lidokain SAD Pharmaceutical Form: Injection INN or Proposed INN: LIDOCAINE Other descriptive name: LIDOCAINE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Con

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • Age > 18 years old • Subjects who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and re-strictions. • ASA 1 • Male • BMI 18–30 • Physical exercise 1-3 hours/week 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Subjects who cannot cooperate with the study. • Subjects who cannot understand or speak Danish. • Subjects with allergy to the medicines used in the study. • Subjects suffering from alcohol and/or drug abuse – based on the inves-tigator's opinion. • Pathology or previous surgery or trauma to the lower limb. • Intense exercise 24 h before the tests • Intake of any analgesics 24 h prior to baseline measurements.

Design outcomes

Primary

Measure	Time frame
Main Objective: We do not know the optimal volume for the ACB and we find it relevant to investigate to what extent and which parts of the quadriceps muscle gets affected when different volumes of a local anesthetic are injected into the adductor canal. Selective affection of the different components of the femoral quadriceps muscle can be assessed by non-invasive EMG record-ings. Further, the quadriceps femoris muscle strength will be evaluated by measuring the MVIC following the different volumes. The EMG recordings will be voluntary (vEMG) meas-ured during MVIC and stimulated (sEMG). sEMG is measured during transcutaneous electri-cal stimulation of the femoral nerve. The healthy volunteers will not gain from this study but it is our firm belief that the obtained knowledge can help future TKA patients as we hope to come closer in answering the ques-tion; “what is the optimal volume for the ACB?” — Thereby, enabling us to provide pain relief with fewer side effects and adverse events.;Secondary Objective: not applicable;Primary end point(s): • Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus medialis, expressed as percentage of the pre-block value. ;Timepoint(s) of evaluation of this end point: Pre block and one hour post-block	—

Measure

Time frame

Main Objective: We do not know the optimal volume for the ACB and we find it relevant to investigate to what extent and which parts of the quadriceps muscle gets affected when different volumes of a local anesthetic are injected into the adductor canal. Selective affection of the different components of the femoral quadriceps muscle can be assessed by non-invasive EMG record-ings. Further, the quadriceps femoris muscle strength will be evaluated by measuring the MVIC following the different volumes. The EMG recordings will be voluntary (vEMG) meas-ured during MVIC and stimulated (sEMG). sEMG is measured during transcutaneous electri-cal stimulation of the femoral nerve. The healthy volunteers will not gain from this study but it is our firm belief that the obtained knowledge can help future TKA patients as we hope to come closer in answering the ques-tion; “what is the optimal volume for the ACB?” — Thereby, enabling us to provide pain relief with fewer side effects and adverse events.;Secondary Objective: not applicable;Primary end point(s): • Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus medialis, expressed as percentage of the pre-block value. ;Timepoint(s) of evaluation of this end point: Pre block and one hour post-block

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Secondary

Measure	Time frame
Secondary end point(s): • Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus lateralis, expressed as percentage of the pre-block value. • Difference between groups, one hour post-block, in MVIC expressed as percentage of the pre-block value • Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus medialis, expressed as percentage of the pre-block value. • Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus lateralis, expressed as percentage of the pre-block value. • Correlation between volume and MVIC. MVIC expressed as a percentage of the pre-block value. • Difference in proportions between ACB-groups having an affection of both the saphe-nous nerve and the vastus medialis (but no other components of the quadriceps femoris muscle), one hour post block evaluated by EMG. (see below for establishment of the cut-off point for affected/not affected: ;Timepoint(s) of evaluation of this end point: Pre block and one hour post block	—

Measure

Time frame

Secondary end point(s): • Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus lateralis, expressed as percentage of the pre-block value. • Difference between groups, one hour post-block, in MVIC expressed as percentage of the pre-block value • Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus medialis, expressed as percentage of the pre-block value. • Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus lateralis, expressed as percentage of the pre-block value. • Correlation between volume and MVIC. MVIC expressed as a percentage of the pre-block value. • Difference in proportions between ACB-groups having an affection of both the saphe-nous nerve and the vastus medialis (but no other components of the quadriceps femoris muscle), one hour post block evaluated by EMG. (see below for establishment of the cut-off point for affected/not affected: ;Timepoint(s) of evaluation of this end point: Pre block and one hour post block

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Countries

Denmark

Contacts

Public ContactGentofte Hospital, Dept. of anaest.

Ulrik Grevstad

ulrik.grevstad@hotmail.com004538673892

Outcome results

None listed

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