Protective Nerve Stimulation in Regional Anesthesia

NCT03291691 | Suspended

• 1 other identifier: ProNerv
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Nerve Block; Brachial Plexus Block

Keywords

Protective Nerve Stimulation; Regional Anesthesia; Sciatic nerve block; femoral nerve block; brachial plexus block

Outcome Measures

Primary Outcomes (1)

• Effectivity

  Effective motor blockade and sensitive blockade at fixed timepoints

  Duration of preparation, surgery and recovery room (an average of 4 hours)

Secondary Outcomes (7)

• Muscle contractions

  Duration of preparation, surgery and recovery room (an average of 4 hours)

• Paresthesia

  Duration of preparation, surgery and recovery room (an average of 4 hours)

• Pain while blocking

  Duration of preparation, surgery and recovery room (an average of 4 hours)

• Pain after surgery

  Duration of preparation, surgery and recovery room (an average of 4 hours)

• Satisfaction

  Duration of preparation, surgery and recovery room (an average of 4 hours)

Other Outcomes (4)

• Bloody Tap

  Duration of preparation, surgery and recovery room (an average of 4 hours)

• Postoperative Nausea and Vomiting

  Duration of preparation, surgery and recovery room (an average of 4 hours)

• pruritus

  Duration of preparation, surgery and recovery room (an average of 4 hours)

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 female and male patients undergoing elective surgery with a regional block at Charité -Universitätsmedizin Berlin

You may qualify if:

• written informed consent
• age of 18 or older
• elective surgery patients at Campus Charité Mitte with clinical benefit of regional anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, 10117, Germany

Location

Related Publications (9)

• 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.

  PMID: 22391670 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.

  PMID: 19550303 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.

  PMID: 22050512 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.

  PMID: 26666693 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.

  PMID: 21519043 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.

  PMID: 24284806 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.

  PMID: 27778324 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.

  PMID: 27108824 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.

  PMID: 17377115 BACKGROUND

Study Officials

• Jürgen Birnbaum, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Consultant of the Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: September 25, 2017
• Study Start: September 20, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)