Protective Nerve Stimulation in Regional Anesthesia

Anesthesia, Local Clinical Trial

— ProNerv  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03291691
• Other study ID #: ProNerv
• Status: Suspended
• Start date: September 20, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Brachial Plexus Block
• Nerve Block

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin Campus Charité Mitte	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Vassiliou T, Müller 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. — View Citation

Wiesmann T, Bornträger A, Vassiliou T, Hadzic A, Wulf H, Müller 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	pruritus	Appearance of pruritus before, during and after the block (yes/no)	Duration of preparation, surgery and recovery room (an average of 4 hours)
Other	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)
Primary	Effectivity	Effective motor blockade and sensitive blockade at fixed timepoints	Duration of preparation, surgery and recovery room (an average of 4 hours)
Secondary	Muscle contractions	Number of expected and unexpected muscle contractions	Duration of preparation, surgery and recovery room (an average of 4 hours)
Secondary	Paresthesia	Number of expected and unexpected paresthesia	Duration of preparation, surgery and recovery room (an average of 4 hours)
Secondary	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)
Secondary	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)
Secondary	Satisfaction	Satisfaction of the patient in a 6-step Likert scale	Duration of preparation, surgery and recovery room (an average of 4 hours)
Secondary	Impedance	impedance measured by the nerve stimulator while proceeding with the needle	Duration of preparation, surgery and recovery room (an average of 4 hours)
Secondary	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)