Protective Nerve Stimulation in Regional Anesthesia (ProNerv)

The Use of Protective Nerve Stimulation in Different Regional Anesthetic Blocks (Interscalene, Axillary, Femoral and Sciatic Nerve Blocks)

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.

Study Overview

• Status: Suspended
• Conditions: Anesthesia, Local; Brachial Plexus Block; Nerve Block

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin Campus Charité Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Other Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Jürgen Birnbaum, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Protective Nerve Stimulation; Sciatic nerve block; femoral nerve block; brachial plexus block
• Other Study ID Numbers: ProNerv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No