Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
60 participants
OBSERVATIONAL
2017-09-20
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard of care: SCI
Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided sciatic nerve block. N=15.
No interventions assigned to this group
Standard of care: FEM
Patients at Charite, with lower limb surgery undergoing a protective performed ultrasound guided femoral nerve block. N=15.
No interventions assigned to this group
Standard of care: ISB
Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided interscalene plexus block. N=15.
No interventions assigned to this group
Standard of care: AXP
Patients at Charite, with upper limb surgery undergoing a protective performed ultrasound guided axillary plexus block. N=15.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* age of 18 or older
* elective surgery patients at Campus Charité Mitte with clinical benefit of regional anesthesia
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Jurgen Birnbaum
Principal Investigator and Consultant of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
Principal Investigators
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Jürgen Birnbaum, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité - Universitätsmedizin Berlin Campus Charité Mitte
Berlin, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ProNerv
Identifier Type: -
Identifier Source: org_study_id
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