CTIS2023-505263-37-00
Active, not recruiting
Phase 1
The effect of the Popliteal Plexus Block on the motor function of the leg - a randomized, controlled, blinded study in volunteers
Region Midtjylland0 sites40 target enrollmentApril 21, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Region Midtjylland
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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