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for organizational reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care: SCI | Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided sciatic nerve block. N=15. | ||
| Standard of care: FEM | Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided femoral nerve block. N=15. | ||
| Standard of care: ISB | Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided interscalene plexus block. N=15. | ||
| Standard of care: AXP | Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided axillary plexus block. N=15. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectivity | Effective motor blockade and sensitive blockade at fixed timepoints | Duration of preparation, surgery and recovery room (an average of 4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle contractions | Number of expected and unexpected muscle contractions | Duration of preparation, surgery and recovery room (an average of 4 hours) |
| Paresthesia | Number of expected and unexpected paresthesia |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Postoperative Nausea and Vomiting | Appearance of PONV before, during and after the block (yes/no) |
Inclusion Criteria:
Exclusion Criteria:
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60 female and male patients undergoing elective surgery with a regional block at Charité -Universitätsmedizin Berlin
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| Name | Affiliation | Role |
|---|---|---|
| Jürgen Birnbaum, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin Campus Charité Mitte | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22391670 | Background | Salem MH, Winckelmann J, Geiger P, Mehrkens HH, Salem KH. Electrostimulation with or without ultrasound-guidance in interscalene brachial plexus block for shoulder surgery. J Anesth. 2012 Aug;26(4):610-3. doi: 10.1007/s00540-012-1366-x. Epub 2012 Mar 4. | |
| 19550303 | Background | Klaastad O, Sauter AR, Dodgson MS. Brachial plexus block with or without ultrasound guidance. Curr Opin Anaesthesiol. 2009 Oct;22(5):655-60. doi: 10.1097/ACO.0b013e32832eb7d3. |
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| 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. | 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. | Duration of preparation, surgery and recovery room (an average of 4 hours) |
| Satisfaction | Satisfaction of the patient in a 6-step Likert scale | Duration of preparation, surgery and recovery room (an average of 4 hours) |
| Impedance | impedance measured by the nerve stimulator while proceeding with the needle | 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 | Duration of preparation, surgery and recovery room (an average of 4 hours) |
| Duration of preparation, surgery and recovery room (an average of 4 hours) |
| pruritus | Appearance of pruritus before, during and after the block (yes/no) | 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 | Duration of preparation, surgery and recovery room (an average of 4 hours) |
| 22050512 | Background | Dillane D, Tsui BC. Is there still a place for the use of nerve stimulation? Paediatr Anaesth. 2012 Jan;22(1):102-8. doi: 10.1111/j.1460-9592.2011.03729.x. Epub 2011 Nov 4. |
| 26666693 | Background | Vassiliou T, Muller HH, Limberg S, De Andres J, Steinfeldt T, Wiesmann T. Risk evaluation for needle-nerve contact related to electrical nerve stimulation in a porcine model. Acta Anaesthesiol Scand. 2016 Mar;60(3):400-6. doi: 10.1111/aas.12664. Epub 2015 Dec 15. |
| 21519043 | Background | Dexter F, Candiotti KA. Multicenter assessment of the Iowa Satisfaction with Anesthesia Scale, an instrument that measures patient satisfaction with monitored anesthesia care. Anesth Analg. 2011 Aug;113(2):364-8. doi: 10.1213/ANE.0b013e318217f804. Epub 2011 Apr 25. |
| 24284806 | Background | Wiesmann T, Borntrager A, Vassiliou T, Hadzic A, Wulf H, Muller HH, Steinfeldt T. Minimal current intensity to elicit an evoked motor response cannot discern between needle-nerve contact and intraneural needle insertion. Anesth Analg. 2014 Mar;118(3):681-6. doi: 10.1213/ANE.0b013e3182a94454. |
| 27778324 | Background | Wiesmann T, Steinfeldt T, Exner M, Nimphius W, De Andres J, Wulf H, Schwemmer U. Intraneural injection of a test dose of local anesthetic in peripheral nerves - does it induce histological changes in nerve tissue? Acta Anaesthesiol Scand. 2017 Jan;61(1):91-98. doi: 10.1111/aas.12825. Epub 2016 Oct 25. |
| 27108824 | Background | Sen O, Sayilgan NC, Tutuncu AC, Bakan M, Koksal GM, Oz H. Evaluation of sciatic nerve damage following intraneural injection of bupivacaine, levobupivacaine and lidocaine in rats. Braz J Anesthesiol. 2016 May-Jun;66(3):272-5. doi: 10.1016/j.bjane.2014.09.012. Epub 2015 Mar 12. |
| 17377115 | Background | Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. doi: 10.1213/01.ane.0000258740.17193.ec. |