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

NCT05464862 | Completed Phase 4 DMC

• 1 other identifier: 2022-501206-35-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Arthritis; Anesthesia, Local; Post Surgical Pain

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• MVIC knee extension

  Measured pre block and at 45 minutes post block

• cMAP (compoud motor action potention) gatrocnemius

  Measured pre block and at 45 minutes post block

• cMAP tibialis anterior

  Measured pre block and at 45 minutes post block

• cMAP vastus medialis

  Measured pre block and at 45 minutes post block

• cMAP vastus lateralis

  Measured pre block and at 45 minutes post block

Study Arms (5)

Group A

EXPERIMENTAL

Popliteal Plexus Block given with 10 ml of Lidocaine Hydrochloride 10 mg/ml

Drug: Popliteal Plexus Block with 10 ml

Groups B

EXPERIMENTAL

Popliteal Plexus Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml

Drug: Popliteal Plexus Block with 20 ml

Group C

EXPERIMENTAL

Popliteal Plexus Block given with 30 ml of Lidocaine Hydrochloride 10 mg/ml

Drug: Popliteal Plexus Block with 30 ml

Group FNB

ACTIVE COMPARATOR

Femoral Nerve Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml

Drug: Femoral Nerve Block

Groups SNB

ACTIVE COMPARATOR

Sciatic Nerve Block given with 20 ml og Lidocaine Hydrochloride 10 mg/ml

Drug: Sciatic Nerve Block

Interventions

Popliteal Plexus Block with 10 ml DRUG

Ultrasound-guided Popliteal Plexus Block using 10 ml of of Lidocaine Hydrochloride 10 mg/ml

Group A

Popliteal Plexus Block with 20 ml DRUG

Ultrasound-guided Popliteal Plexus Block using 20 ml of of Lidocaine Hydrochloride 10 mg/ml

Groups B

Popliteal Plexus Block with 30 ml DRUG

Ultrasound-guided Popliteal Plexus Block using 30 ml of of Lidocaine Hydrochloride 10 mg/ml

Group C

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.

Group FNB

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.

Groups SNB

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Charlotte Runge: lead
• Danish Society of Anesthesiology and Intensive Care Medicine: collaborator
• University of Aarhus: collaborator
• The Danish Rheumatism Association: collaborator

Study Sites (1)

Elective Surgery Center at Silkeborg Regional Hospital

Silkeborg, Region Midt, 8600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40185510 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Johan Sørensen, MD

  Aarhus Universitet (Aarhus)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Specialist in Anesthesiology, PhD, Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 19, 2022
• Study Start: September 29, 2023
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At the end of the study analysis
• Access Criteria: Permission by investigators

Locations

DK (1)