Knee ArthritisPhase 4NCT05464862

The Effect of PPB Using 10, 20 and 30 ml of Lidocaine, Study on Volunteers

A Phase 4 study testing Popliteal Plexus Block with 10 ml, Popliteal Plexus Block with 20 ml and Popliteal Plexus Block with 30 ml in people with Knee Arthritis and Anesthesia, Local, run by Charlotte Runge 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 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. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Knee Arthritis, Anesthesia, Local, Post Surgical Pain
What is being tested?: Popliteal Plexus Block with 10 ml, Popliteal Plexus Block with 20 ml and Popliteal Plexus Block with 30 ml
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteDenmark
Study dates: 29 Sep 2023to 19 Oct 2023
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 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

ASA 1-2
Ability to give their written informed consent to participating in the study after having fully understood the contents of the study

Who cannot join

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 investigator's opinion.
Pathology or previous major surgery to the lower limb.
Intake of any analgesics 24 hours prior to baseline measurements.

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BMI > 35
Active signs of infection in the cutaneous area of injection
Subjects diagnosed with epilepsy, neurologic diseases, severe hypoxia or respiratory depression, hypovolemia, shock, bradycardia or Wolff-Parkinson-Whites syndrome
Subjects with a positive pregnancy test**
Subjects diagnosed with cardiovascular disease or heart failure
Subjects diagnosed with partial or complete cardiac block
Subjects in daily treatment with class III antiarrhythmics (e.g. amiodarone)
Subjects in daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics
Subjects diagnosed with severe liver disease or reduced kidney function

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Elective Surgery Center at Silkeborg Regional Hospital
Silkeborg, Region Midt, 8600

Other trials in Denmark

About this study

Official title: The Effect of the Popliteal Plexus Block on the Motor Function of the Leg - a Randomized, Controlled, Blinded Study in Volunteers

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.

Read the detailed description

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 A: PPB with 10 ml of lidocaine 1%, 20 legs.
Group B: PPB with 20 ml of lidocaine 1%, 20 legs.
Group C: PPB with 30 ml of lidocaine 1%, 20 legs.
Group FNB: FNB with 20 ml of lidocaine 1%, 10 legs.
Group SNB: SNB with 20 ml of lidocaine 1%, 10 legs.

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.

Conditions: Knee Arthritis, Anesthesia, Local, Post Surgical Pain
Being tested: Popliteal Plexus Block with 10 ml, Popliteal Plexus Block with 20 ml, Popliteal Plexus Block with 30 ml, Femoral Nerve Block, Sciatic Nerve Block
Medical subject headings: Pain, Postoperative

What participants receive

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

Popliteal Plexus Block with 10 mlDrug
Ultrasound-guided Popliteal Plexus Block using 10 ml of of Lidocaine Hydrochloride 10 mg/ml
Popliteal Plexus Block with 20 mlDrug
Ultrasound-guided Popliteal Plexus Block using 20 ml of of Lidocaine Hydrochloride 10 mg/ml
Popliteal Plexus Block with 30 mlDrug
Ultrasound-guided Popliteal Plexus Block using 30 ml of of Lidocaine Hydrochloride 10 mg/ml
Femoral Nerve BlockDrug
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 BlockDrug
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.

Study groups in NCT05464862
Study group	Role	What they receive
Group A	Experimental	Popliteal Plexus Block given with 10 ml of Lidocaine Hydrochloride 10 mg/ml Receives: Drug: Popliteal Plexus Block with 10 ml
Groups B	Experimental	Popliteal Plexus Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml Receives: Drug: Popliteal Plexus Block with 20 ml
Group C	Experimental	Popliteal Plexus Block given with 30 ml of Lidocaine Hydrochloride 10 mg/ml Receives: Drug: Popliteal Plexus Block with 30 ml
Group FNB	Active comparator	Femoral Nerve Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml Receives: Drug: Femoral Nerve Block
Groups SNB	Active comparator	Sciatic Nerve Block given with 20 ml og Lidocaine Hydrochloride 10 mg/ml Receives: Drug: Sciatic Nerve Block

What is being measured

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

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: 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: Measured pre block and at 45 minutes post block

Secondary outcomes (6)

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: Measured pre block and at 45 minutes post block
cMAP (compoud motor action potention) gatrocnemius
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: 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: 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: 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: 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: Measured pre block and at 45 minutes post block

Timeline

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

29 Sep 202319 Oct 2023

First posted19 Jul 2022
Study start29 Sep 2023
Primary completion19 Oct 2023
Study completion19 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Knee ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 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.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05464862
Sponsor's protocol ID: 2022-501206-35-00
Status last verified: Apr 2024
First submitted: 5 Jul 2022
Last updated: 11 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be shared after acceåtance from The Danish Data Protection Agency

Publications

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. 2026 Aug 5;51(8):924-930. doi: 10.1136/rapm-2025-106557.
PubMed 40185510

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of the Popliteal Plexus Block on the Motor Function of the Leg - a Randomized, Controlled, Blinded Study in Volunteers
ClinicalTrials.gov ID: NCT05464862
Acronym / sponsor ID: 2022-501206-35-00
Conditions: Knee Arthritis, Anesthesia, Local, Post Surgical Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Charlotte RungeUniversity, hospital or other
Collaborators: Danish Society of Anesthesiology and Intensive Care Medicine, University of Aarhus, The Danish Rheumatism Association
Study start: 29 Sep 2023 (actual)
Primary completion: 19 Oct 2023 (actual)
Study completion: 19 Oct 2023 (actual)
First posted: 19 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Groups name, type of peripheral nerve block, study medication dosage and number of legs in the group:

Group A: PPB with 10 ml of lidocaine 1%, 20 legs.
Group B: PPB with 20 ml of lidocaine 1%, 20 legs.
Group C: PPB with 30 ml of lidocaine 1%, 20 legs.
Group FNB: FNB with 20 ml of lidocaine 1%, 10 legs.
Group SNB: SNB with 20 ml of lidocaine 1%, 10 legs.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5
Model description: 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.

Arm	Type	Receives
Group A	Experimental	Drug: Popliteal Plexus Block with 10 mlPopliteal Plexus Block given with 10 ml of Lidocaine Hydrochloride 10 mg/ml
Groups B	Experimental	Drug: Popliteal Plexus Block with 20 mlPopliteal Plexus Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml
Group C	Experimental	Drug: Popliteal Plexus Block with 30 mlPopliteal Plexus Block given with 30 ml of Lidocaine Hydrochloride 10 mg/ml
Group FNB	Active comparator	Drug: Femoral Nerve BlockFemoral Nerve Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml
Groups SNB	Active comparator	Drug: Sciatic Nerve BlockSciatic Nerve Block given with 20 ml og Lidocaine Hydrochloride 10 mg/ml

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

ASA 1-2
Ability to give their written informed consent to participating in the study after having fully understood the contents of the study

Key exclusion criteria (15 listed)

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 investigator's opinion.
Pathology or previous major surgery to the lower limb.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Popliteal Plexus Block with 10 mlUltrasound-guided Popliteal Plexus Block using 10 ml of of Lidocaine Hydrochloride 10 mg/ml	Drug	Group A
Popliteal Plexus Block with 20 mlUltrasound-guided Popliteal Plexus Block using 20 ml of of Lidocaine Hydrochloride 10 mg/ml	Drug	Groups B
Popliteal Plexus Block with 30 mlUltrasound-guided Popliteal Plexus Block using 30 ml of of Lidocaine Hydrochloride 10 mg/ml	Drug	Group C
Femoral Nerve BlockUltrasound-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.	Drug	Group FNB
Sciatic Nerve BlockUltrasound-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.	Drug	Groups SNB

Primary outcome

MVIC (Maximum Voluntary Isometric Contraction) ankle plantarflexion
Time frame: Measured pre block and at 45 minutes post block
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.
MVIC ankle dorsiflexion
Time frame: Measured pre block and at 45 minutes post block
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.

6 secondary outcomes

MVIC knee extension
Time frame: Measured pre block and at 45 minutes post block
cMAP (compoud motor action potention) gatrocnemius
Time frame: Measured pre block and at 45 minutes post block
cMAP tibialis anterior
Time frame: Measured pre block and at 45 minutes post block
cMAP vastus medialis
Time frame: Measured pre block and at 45 minutes post block
cMAP vastus lateralis
Time frame: Measured pre block and at 45 minutes post block
Saphenus senory test
Time frame: Measured pre block and at 45 minutes post block

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Derived from this study: PubMed 40185510Sorensen 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. 2026 Aug 5;51(8):924-930. doi: 10.1136/rapm-2025-106557.
Individual participant dataSharing planned: Yes. Data will be shared after acceåtance from The Danish Data Protection Agency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johan Sørensen, MD principal investigator

Aarhus Universitet (Aarhus)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 15 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 11 Apr 2024. 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. 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?

MVIC (Maximum Voluntary Isometric Contraction) ankle plantarflexion (time frame: Measured pre block and at 45 minutes post block). The study lists 2 primary outcomes in all. 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 NCT05464862, 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 11 Apr 2024.