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The effect of the Popliteal Plexus Block on muscle function of the leg - a scientific trial in healthy volunteers
EU CTIS ID: 2023-505263-37-00
What this study is testing
The aim of this study is to evaluate the effect of the Popliteal Plexus Block (PPB) on motor nerve branches of the sciatic and femoral nerve, when using volumes of 10 ml, 20 ml or 30 ml of local anesthetic.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >= 18 years old
- ASA class 1-2 (American Society of Anesthesiologist classification)
- Ability to give their written informed consent to participating in the study after having fully understood the contents of the study
You likely can't join if
- Age > 64 years
- 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 (Women < 60 years must demonstrate a negative pregnancy test (25 mIU/ml) prior to inclusion. Pregnancy test is offered at the trial site at the day of treatment. If the woman fulfills one of the following criteria of not being pregnant, a pregnancy test is not required: 1. Menopausal: woman +50 years old and no period for more than 1 year without any other obvious explanation, or if menopause has been confirmed by measuring LH and FSH. 2. Pregnancy is not possible due to use of highly effective birth control, sterilization, living in a homosexual relationship, living in total sexual abstinence, or hysterectomy.
- 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)
See the full eligibility criteria
- Age >= 18 years old
- ASA class 1-2 (American Society of Anesthesiologist classification)
- Ability to give their written informed consent to participating in the study after having fully understood the contents of the study
- Age > 64 years
- 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 (Women < 60 years must demonstrate a negative pregnancy test (25 mIU/ml) prior to inclusion. Pregnancy test is offered at the trial site at the day of treatment. If the woman fulfills one of the following criteria of not being pregnant, a pregnancy test is not required: 1. Menopausal: woman +50 years old and no period for more than 1 year without any other obvious explanation, or if menopause has been confirmed by measuring LH and FSH. 2. Pregnancy is not possible due to use of highly effective birth control, sterilization, living in a homosexual relationship, living in total sexual abstinence, or hysterectomy.
- 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, as the toxic effects are additive
- Subjects diagnosed with severe liver disease or reduced kidney function
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.