An observational study in Anesthesia, Local, Nerve Block and Brachial Plexus Block, sponsored by Charite University, Berlin, Germany. Suspended at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Charite University, Berlin, Germany · 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.
All patients will get the regional block they need for the elective surgery. Before starting the block a standard monitoring will be established. After applying the monitoring the block will be performed by an experienced anesthetist in supervision of another experienced anesthetist. The nerve stimulator is set on a fixed current of 1.0 mA and a block without motoric response on this current is tried. Ultrasound images are saved. After performing the regional anesthesia the further anesthetic procedure will be carried out and the surgery will take place. After surgery the patients will be transported to the recovery room or Postanesthesia care unit.
60 female and male patients undergoing elective surgery with a regional block at Charité -Universitätsmedizin Berlin
Exclusion Criteria:
Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided sciatic nerve block. N=15.
Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided femoral nerve block. N=15.
Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided interscalene plexus block. N=15.
Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided axillary plexus block. N=15.
Effectivity
Effective motor blockade and sensitive blockade at fixed timepoints
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Muscle contractions
Number of expected and unexpected muscle contractions
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Paresthesia
Number of expected and unexpected paresthesia
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
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.
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
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.
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Satisfaction
Satisfaction of the patient in a 6-step Likert scale
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Impedance
impedance measured by the nerve stimulator while proceeding with the needle
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Changes of impedance
changes of impedance measured by the nerve stimulator while proceeding with the needle
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Bloody Tap
Appearance of Bloody Tap before, during and after the block (yes/no)
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Postoperative Nausea and Vomiting
Appearance of PONV before, during and after the block (yes/no)
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
pruritus
Appearance of pruritus before, during and after the block (yes/no)
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Analgetics consumption
Amount of opioids needed before, during and after the surgery until the patient leaves the recovery unit
Time frame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Plan to share: No
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Charite University, Berlin, Germany