Anesthesia, Local Clinical Trial
— ProNervOfficial title:
The Use of Protective Nerve Stimulation in Different Regional Anesthetic Blocks (Interscalene, Axillary, Femoral and Sciatic Nerve Blocks)
Verified date | January 2022 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Peripheral nerve blocks can be conducted with ultrasound, electrical nerve stimulation or landmark technique or a combination of this techniques. Whether a regional block should be conducted with a combination of those different possibilities is highly discussed. In this study the investigators want to show the effectiveness of new standard way of combined use of ultrasound and nerve stimulation, they call protective nerve stimulation. According to ethical vote we are conducting an observational study.
Status | Suspended |
Enrollment | 60 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - written informed consent - age of 18 or older - elective surgery patients at Campus Charité Mitte with clinical benefit of regional anesthesia Exclusion Criteria: - existing contraindication for regional nerve blocks or the use of Protective Nerve Stimulation - patients who undergo outpatient treatment - allergy against local anesthetics - age under 18 years - Lacking willingness to take part in the study - ASA PS score of 4 or more - preexisting neural damage in the effect area - Diabetes mellitus, alcohol use disorder - Participation in other prospective clinical interventional trials - Accommodation in an institution due to an official or judicial order |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin Campus Charité Mitte | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Bloody Tap | Appearance of Bloody Tap before, during and after the block (yes/no) | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Other | Postoperative Nausea and Vomiting | Appearance of PONV before, during and after the block (yes/no) | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Other | pruritus | Appearance of pruritus before, during and after the block (yes/no) | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Other | Analgetics consumption | Amount of opioids needed before, during and after the surgery until the patient leaves the recovery unit | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Primary | Effectivity | Effective motor blockade and sensitive blockade at fixed timepoints | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Secondary | Muscle contractions | Number of expected and unexpected muscle contractions | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Secondary | Paresthesia | Number of expected and unexpected paresthesia | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Secondary | Pain while blocking | Does the patient have pain while blocking? Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V). For patients unable of pain self-assessment (e.g. ventilated patients, patients in delirious state or patients with stroke affecting language skills) observer-rated pain scales will be applied: Behavioural Pain Scale (BPS for ventilated) and BPS-NI (for non-ventilated) patients. | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Secondary | Pain after surgery | Does the patient have pain after surgery? Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V). For patients unable of pain self-assessment (e.g. ventilated patients, patients in delirious state or patients with stroke affecting language skills) observer-rated pain scales will be applied: Behavioural Pain Scale (BPS for ventilated) and BPS-NI (for non-ventilated) patients. | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Secondary | Satisfaction | Satisfaction of the patient in a 6-step Likert scale | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Secondary | Impedance | impedance measured by the nerve stimulator while proceeding with the needle | Duration of preparation, surgery and recovery room (an average of 4 hours) | |
Secondary | Changes of impedance | changes of impedance measured by the nerve stimulator while proceeding with the needle | Duration of preparation, surgery and recovery room (an average of 4 hours) |
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