Clinical trial NCT03291691: Protective Nerve Stimulation in Regional Anesthesia
Official title: The Use of Protective Nerve Stimulation in Different Regional Anesthetic Blocks (Interscalene, Axillary, Femoral and Sciatic Nerve Blocks)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Anesthesia, Local
Nerve Block
Brachial Plexus Block
Keywords: Protective Nerve Stimulation
Regional Anesthesia
Sciatic nerve block
femoral nerve block
brachial plexus block
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 female and male patients undergoing elective surgery with a regional block at Charité -Universitätsmedizin Berlin

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectivity
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Secondary outcomes:
measure: Muscle contractions
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: Paresthesia
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: Pain while blocking
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: Pain after surgery
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: Satisfaction
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: Impedance
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: Changes of impedance
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Other outcomes:
measure: Bloody Tap
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: Postoperative Nausea and Vomiting
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: pruritus
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
measure: Analgetics consumption
timeFrame: Duration of preparation, surgery and recovery room (an average of 4 hours)
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Campus Charité Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jürgen Birnbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.