Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Danish Society of Anesthesiology and Intensive Care Medicine | UNKNOWN |
| University of Aarhus | OTHER |
| The Danish Rheumatism Association | OTHER |
Not provided
Not provided
Not provided
The aim of this study is to evaluate the Popliteal Plexus Block (PPB) effect on motor nerve branches of the sciatic and femoral nerve, when using different volumes of local anesthetics for PPB.
The hypothesis is that increasing the volume of anesthetics used for PPB will spread to the sciatic nerve leading to a reduced muscle strength in the lower leg and decreased nerve conduction velocity in the nerve to gastrocnemius muscle (the tibial nerve) and the nerve to anterior tibial muscle (the deep fibular nerve).
The effects will be evaluated by maximum voluntary isometric contraction (MVIC) of the lower leg muscles and by recordings of the compound muscle action potential (cMAP) of the gastrocnemius and tibialis anterior muscles - a motor nerve conduction study.
In addition, evaluation of PPBs effect on the femoral nerve is done by MVIC of the quadriceps femoris muscle, cMAP of the vastus medialis and vastus lateralis muscles and by a sensory nerve conduction study of the saphenous nerve.
A total number of 40 volunteers will be enrolled in the study. Each volunteer will receive two peripheral nerve blocks (one in each leg) on the day of participation. This will result in 80 peripheral nerve blocks. The types of nerve blocks given to each leg on each volunteer will depend on randomization.
The 80 nerve blocks are divided into five groups specified by type of nerve block, volume of anesthetic used, and respective numbers of legs used in the group. The groups and specifications are listed here:
Groups name, type of peripheral nerve block, study medication dosage and number of legs in the group:
Group FNB of SNB are performed unblinded and works as active comparatives for model control, in order to establish reference points for when a nerve is considered affected.
Prior to nerve block procedure , pre block assessments are obtained in the following order:
Sensory test of the saphenous nerve.
MVIC by ankle plantarflexion.
MVIC by ankle dorsiflexion.
MVIC by knee extension.
Compound muscle action potential (cMAP) recordings in the following order:
Nerve to vastus medialis muscle
Nerve to vastus lateralis muscle
Nerve to tibialis anterior muscle
Nerve to gastrocnemius muscle
60 minutes after the block performance, post block assessments are done. Values are obtained in the same order as for the pre block assessments.
A peripheral intravenous line is inserted prior to the procedure of the peripheral nerve block is performed. At the discretion of the anesthetist, up to 20 mg Propofol IV may be provided to ease the patient during the nerve block procedure. The volunteer is monitored with continuous electrocardiography and pulse oximetry for the first 30 minutes after block performance and clinically hereafter. Final check by an investigator to ensure the volunteer is ready to go home. If the muscle strength is reduced, the volunteer will not be sent home before the ability to walk safely with crutches is ensured.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Popliteal Plexus Block given with 10 ml of Lidocaine Hydrochloride 10 mg/ml |
|
| Groups B | Experimental | Popliteal Plexus Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml |
|
| Group C | Experimental | Popliteal Plexus Block given with 30 ml of Lidocaine Hydrochloride 10 mg/ml |
|
| Group FNB | Active Comparator | Femoral Nerve Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml |
|
| Groups SNB | Active Comparator | Sciatic Nerve Block given with 20 ml og Lidocaine Hydrochloride 10 mg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Popliteal Plexus Block with 10 ml | Drug | Ultrasound-guided Popliteal Plexus Block using 10 ml of of Lidocaine Hydrochloride 10 mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| MVIC (Maximum Voluntary Isometric Contraction) ankle plantarflexion | Difference between group A, B and C in post block MVIC by ankle plantarflexion, expressed as percentage change of the pre block value. MVIC is measured using a handheld dynamometer. | Measured pre block and at 45 minutes post block |
| MVIC ankle dorsiflexion | Difference between group A, B and C in post block MVIC by ankle dorsiflexion, expressed as a percentage change of the pre block value. MVIC is measured using a handheld dynamometer. | Measured pre block and at 45 minutes post block |
| Measure | Description | Time Frame |
|---|---|---|
| MVIC knee extension | Difference between group A, B and C in post block MVIC by knee extension, expressed as a percentage change of the pre block value. MVIC is measured using a handheld dynamometer. | Measured pre block and at 45 minutes post block |
| cMAP (compoud motor action potention) gatrocnemius |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johan Sørensen, MD | Aarhus Universitet (Aarhus) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elective Surgery Center at Silkeborg Regional Hospital | Silkeborg | Region Midt | 8600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40185510 | Derived | Sorensen JK, Grevstad U, Qerama E, Bruun LS, Nikolajsen L, Runge C. Effect of local anesthetic volume for popliteal plexus block on motor nerve conduction and muscle function in the leg: a randomized clinical trial in healthy volunteers. Reg Anesth Pain Med. 2025 Apr 3:rapm-2025-106557. doi: 10.1136/rapm-2025-106557. Online ahead of print. |
Not provided
Not provided
Data will be shared after acceåtance from The Danish Data Protection Agency
At the end of the study analysis
Permission by investigators
Not provided
Not provided
A randomization list is computed by the REDCap administrator from Aarhus University and imported in REDCap.The anesthesiologist and the assistant performing all the nerve blocks, are the only one with access to REDCaps randomization module, where the randomization procedure is made prior to the nerve block procedure.
The randomization list will assign each volunteer to one of six combinations, deciding which type of peripheral nerve block is used for each their leg. One leg equal one observation. The combinations ensure that observations are obtained in even numbers from right and left legs and that the total dose of perineural used lidocaine does not exceed 400 mg per volunteer.
Groups name, type of peripheral nerve block, study medication dosage and number of legs in the group.
Not provided
Not provided
The study is an assessor- and volunteer-blinded randomized study. As different volumes are used for the nerve blocks, the anesthesiologist and an assistant performing the nerve blocks will not be blinded, and therefore have no further contact with the volunteers after the nerve block performance and will not contribute with the data collection or statistical analysis. The nerve block procedure and assessments will take place in different rooms; hence the data collecting assessors will not be present during block performance.To ensure blinding of the volunteer, a draping will hinder the volunteer from observing which volume of lidocaine that is administered during block performance.Group A, B and C are blinded until the data analysis is finished. Group FNB of SNB are unblinded and works as active comparatives for model control, in order to establish reference points for when a nerve is considered affected.
| Popliteal Plexus Block with 20 ml | Drug | Ultrasound-guided Popliteal Plexus Block using 20 ml of of Lidocaine Hydrochloride 10 mg/ml |
|
| Popliteal Plexus Block with 30 ml | Drug | Ultrasound-guided Popliteal Plexus Block using 30 ml of of Lidocaine Hydrochloride 10 mg/ml |
|
| Femoral Nerve Block | Drug | Ultrasound-guided Femoral Nerve Block using 20 ml of of Lidocaine Hydrochloride 10 mg/ml. Is used to find cut-off values that define affection of the femoral nerve. |
|
| Sciatic Nerve Block | Drug | Ultrasound-guided Sciatic Nerve Block using 20 ml of of Lidocaine Hydrochloride 10 mg/ml. Is used to find cut-off values that define affection of the sciatic nerve. |
|
Difference between group A, B and C, in the number of volunteers with affected cMAP of the gastrocnemius muscle, defined as sufficient change from pre block to post block. Cut-off value for sufficient change is determined by SNB group. cMAP is recorded using a motor nerve conduction study. |
| Measured pre block and at 45 minutes post block |
| cMAP tibialis anterior | Difference between group A, B and C, in the number of volunteers with affected cMAP of the tibialis anterior muscle, defined as sufficient change from pre block to post block. Cut-off value for sufficient change is determined by SNB group. cMAP is recorded using a motor nerve conduction study. | Measured pre block and at 45 minutes post block |
| cMAP vastus medialis | Difference between group A, B and C, in the number of volunteers with affected cMAP of the vastus medialis muscle, defined as sufficient change from pre block to post block. Cut-off value for sufficient change is determined by FNB group. cMAP is recorded using a motor nerve conduction study. | Measured pre block and at 45 minutes post block |
| cMAP vastus lateralis | Difference between group A, B and C, in the number of volunteers with affected cMAP of the vastus lateralis muscle, defined as sufficient change from pre block to post block. Cut-off value for sufficient change is determined by FNB group. cMAP is recorded using a motor nerve conduction study. | Measured pre block and at 45 minutes post block |
| Saphenus senory test | Difference between group A, B and C in the number of volunteers with an affected sensory of the saphenous nerve, defined as change, from pre block to post block, in the volunteers ability to discriminate cold in the cutaneous area innervated by the medial crural cutaneous branches of saphenous nerve. | Measured pre block and at 45 minutes post block |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided