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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05464862
• Other study ID #: 2022-501206-35-00
• Status: Completed
• Phase: Phase 4
• Start date: September 29, 2023
• Est. completion date: October 19, 2023

Study information

• Verified date: April 2024
• Source: Regionshospitalet Silkeborg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 19, 2023
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• ASA 1-2

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

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 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

Related Conditions & MeSH terms

• Anesthesia, Local
• Knee Arthritis
• Pain, Postoperative
• Post Surgical Pain

Intervention

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

Locations

Country	Name	City	State
Denmark	Elective Surgery Center at Silkeborg Regional Hospital	Silkeborg	Region Midt

Sponsors (4)

Lead Sponsor	Collaborator
Charlotte Runge	Danish Society of Anesthesiology and Intensive Care Medicine, The Danish Rheumatism Association, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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 pre block and at 45 minutes post block
Secondary	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
Secondary	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
Secondary	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
Secondary	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