The Impact of Nerve Cross Section Area on Sensory Block Onset

NCT03797235 | Completed DMC

• 1 other identifier: BASEC 2018-00939
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to describe a correlation between the nerve cross section and the sensory or motor block onset time. Therefore, different nerve cross sections with their Motor and sensory onset times are compared in order to find a correlation. In the case of discovering a correlation, this could be translated into clinical practice, where a more tailored and individualized approach to performing peripheral nerve blocks would be possible, thus lowering the risks of adverse events occurring.

Conditions

Regional Anesthesia

Keywords

Ultrasound-guided regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Correlation between nerve cross-section and time to complete sensory block of a nerve

  Correlation between the nerve cross-section in mm2 of both nerves (median and ulnar) measured with an ultrasound system and time in minutes from the moment the investigator starts injecting the local anesthetic (LA) around the respective nerves to complete sensory loss in the innervation area of the blocked nerve, assessed by response to light touch, pinprick and cold sensation. This correlation will be expressed in min/ mm2.

  Sensory evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete sensory loss to both cold and pinprick. Expected time frame: 10-60 minutes

Secondary Outcomes (3)

• Correlation between nerve cross-section and time to complete motor block of a nerve

  Motor evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete motor block. Expected time frame: 10-100 minutes

• Correlation between nerve cross-section and the duration of sensory nerve block

  The evaluation of the duration of block will start one hour after the determined complete sensory loss and will be tested every 10 minutes until complete resolution of the sensory block. Expected time frame: 10-300 minutes

• Correlation between the nerve cross-section and duration of motor nerve block

  The evaluation of the duration of sensory block will start one hour after the determined complete motor loss and will be tested every 10 minutes until complete resolution of the motor block. Expected time frame: 10-300min

Study Arms (2)

Dominant Arm

EXPERIMENTAL

Two ultrasound guided nerve blocks (block of the ulnar and median nerve) on the dominant forearm

Procedure: Dominant Arm

Non-dominant arm

ACTIVE COMPARATOR

Two ultrasound guided nerve blocks (block of the ulnar and median nerve) on the non-dominant forearm.

Procedure: Non-dominant arm

Interventions

Dominant Arm PROCEDURE

The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve.

Dominant Arm

Non-dominant arm PROCEDURE

The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve.

Non-dominant arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I - II, both sexes
• ≥ 18 years old
• \< 65 years old
• Written informed consent as documented by signature

You may not qualify if:

• Known allergy or hypersensitivity to a study drug or class of drug.
• Severe coagulopathy.
• History of alcohol abuse or the intake of psychotropic drugs.
• Pregnancy.
• Infection at the injection site or a systemic infection.
• Fever of unknown origin.
• Motor or sensory abnormalities in the arm.
• Previous enrollment into the current study

Sponsors & Collaborators

• Jose Aguirre: lead

Study Sites (1)

Der Balgrist

Zurich, 8008, Switzerland

Location

Related Publications (14)

• Capdevila X, Biboulet P, Morau D, Mannion S, Choquet O. How and why to use ultrasound for regional blockade. Acta Anaesthesiol Belg. 2008;59(3):147-54.

  PMID: 19051446 BACKGROUND

• Lewis SR, Price A, Walker KJ, McGrattan K, Smith AF. Ultrasound guidance for upper and lower limb blocks. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD006459. doi: 10.1002/14651858.CD006459.pub3.

  PMID: 26361135 BACKGROUND

• Eichenberger U, Stockli S, Marhofer P, Huber G, Willimann P, Kettner SC, Pleiner J, Curatolo M, Kapral S. Minimal local anesthetic volume for peripheral nerve block: a new ultrasound-guided, nerve dimension-based method. Reg Anesth Pain Med. 2009 May-Jun;34(3):242-6. doi: 10.1097/AAP.0b013e31819a7225.

  PMID: 19587623 BACKGROUND

• Keplinger M, Marhofer P, Marhofer D, Schroegendorfer K, Haslik W, Zeitlinger M, Mayer CV, Kettner SC. Effective local anaesthetic volumes for sciatic nerve blockade: a clinical evaluation of the ED99. Anaesthesia. 2015 May;70(5):585-90. doi: 10.1111/anae.13013. Epub 2015 Jan 20.

  PMID: 25644578 BACKGROUND

• Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.

  PMID: 25376973 BACKGROUND

• Fenten MG, Schoenmakers KP, Heesterbeek PJ, Scheffer GJ, Stienstra R. Effect of local anesthetic concentration, dose and volume on the duration of single-injection ultrasound-guided axillary brachial plexus block with mepivacaine: a randomized controlled trial. BMC Anesthesiol. 2015 Sep 30;15:130. doi: 10.1186/s12871-015-0110-0.

  PMID: 26423050 BACKGROUND

• Serradell A, Herrero R, Villanueva JA, Santos JA, Moncho JM, Masdeu J. Comparison of three different volumes of mepivacaine in axillary plexus block using multiple nerve stimulation. Br J Anaesth. 2003 Oct;91(4):519-24. doi: 10.1093/bja/aeg215.

  PMID: 14504153 BACKGROUND

• Fredrickson MJ, Abeysekera A, White R. Randomized study of the effect of local anesthetic volume and concentration on the duration of peripheral nerve blockade. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):495-501. doi: 10.1097/AAP.0b013e3182580fd0.

  PMID: 22664978 BACKGROUND

• Latzke D, Marhofer P, Zeitlinger M, Machata A, Neumann F, Lackner E, Kettner SC. Minimal local anaesthetic volumes for sciatic nerve block: evaluation of ED 99 in volunteers. Br J Anaesth. 2010 Feb;104(2):239-44. doi: 10.1093/bja/aep368. Epub 2009 Dec 23.

  PMID: 20034967 BACKGROUND

• Ecoffey C, Oger E, Marchand-Maillet F, Cimino Y, Rannou JJ, Beloeil H; SOS French Regional Anaesthesia Hotline. Complications associated with 27 031 ultrasound-guided axillary brachial plexus blocks: a web-based survey of 36 French centres. Eur J Anaesthesiol. 2014 Nov;31(11):606-10. doi: 10.1097/EJA.0000000000000063.

  PMID: 24809480 BACKGROUND

• Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.

  PMID: 21148659 BACKGROUND

• Hebl JR. The importance and implications of aseptic techniques during regional anesthesia. Reg Anesth Pain Med. 2006 Jul-Aug;31(4):311-23. doi: 10.1016/j.rapm.2006.04.004. No abstract available.

  PMID: 16857551 BACKGROUND

• Rotter ML, Hirschl AM, Koller W. Effect of chlorhexidine-containing detergent, non-medicated soap or isopropanol and the influence of neutralizer on bacterial pathogenicity. J Hosp Infect. 1988 Apr;11(3):220-5. doi: 10.1016/0195-6701(88)90100-4.

  PMID: 2899106 BACKGROUND

• Marhofer P, Eichenberger U, Stockli S, Huber G, Kapral S, Curatolo M, Kettner S. Ultrasonographic guided axillary plexus blocks with low volumes of local anaesthetics: a crossover volunteer study. Anaesthesia. 2010 Mar;65(3):266-71. doi: 10.1111/j.1365-2044.2010.06247.x. Epub 2010 Jan 29.

  PMID: 20121770 BACKGROUND

Study Officials

• José Aguirre, PD Dr Med

  Der Balgrist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 9, 2019
• Study Start: January 19, 2019
• Primary Completion: June 20, 2019
• Study Completion: June 21, 2019
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)