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

NCT05464862 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-11

No results posted yet for this study

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

Interventions

DRUG

Popliteal Plexus Block with 10 ml

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

DRUG

Popliteal Plexus Block with 20 ml

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

DRUG

Popliteal Plexus Block with 30 ml

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

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Danish Society of Anesthesiology and Intensive Care Medicine

    collaborator UNKNOWN
  • University of Aarhus

    collaborator OTHER
  • The Danish Rheumatism Association

    collaborator OTHER
  • Charlotte Runge

    lead OTHER

Principal Investigators

  • Johan Sørensen, MD · Aarhus Universitet (Aarhus)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2023-10-19
Completion
2023-10-19

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464862 on ClinicalTrials.gov