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
Verified date | April 2024 |
Source | Regionshospitalet Silkeborg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Elective Surgery Center at Silkeborg Regional Hospital | Silkeborg | Region Midt |
Lead Sponsor | Collaborator |
---|---|
Charlotte Runge | Danish Society of Anesthesiology and Intensive Care Medicine, The Danish Rheumatism Association, University of Aarhus |
Denmark,
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 |
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