The Impact of Nerve Cross Section Area on Sensory Block Onset

Regional Anesthesia Clinical Trial

Official title:

The Impact of Nerve Cross Section Area on Sensory Block Onset. A Prospective, Monocentric Crossover Study on Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797235
• Other study ID #: BASEC 2018-00939
• Status: Completed
• Phase: N/A
• Start date: January 19, 2019
• Est. completion date: June 21, 2019

Study information

• Verified date: May 2020
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 21, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• ASA I - II, both sexes

• = 18 years old

• < 65 years old

• Written informed consent as documented by signature

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Regional Anesthesia

Intervention

Procedure:
• Dominant Arm
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
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.

Locations

Country	Name	City	State
Switzerland	Der Balgrist	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Jose Aguirre

Country where clinical trial is conducted

Switzerland, 

References & 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Eichenberger U, Stöckli 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. — View Citation

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. — View Citation

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. — View Citation

Hebl JR. The importance and implications of aseptic techniques during regional anesthesia. Reg Anesth Pain Med. 2006 Jul-Aug;31(4):311-23. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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;(9):CD006459. doi: 10.1002/14651858.CD006459.pub3. Review. — View Citation

Marhofer P, Eichenberger U, Stöckli 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between nerve cross-section and time to complete motor block of a nerve	The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and time in minutes from the start of the LA injection around the nerve median and ulnar nerves to the respective onset of the motor block, assessed with a numerical scale ranging from 0 to 5 (0-no muscle contraction visible, 5-normal muscle strength, maximal force against resistance and gravity). This correlation will be expressed in min/ mm2.	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
Secondary	Correlation between nerve cross-section and the duration of sensory nerve block	The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and the duration of the respective sensory block in minutes, as reflected by the return of normal sensation in the innervation area of the respective nerve. This correlation will be expressed in min/ mm2.	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
Secondary	Correlation between the nerve cross-section and duration of motor nerve block	The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and the duration of the respective motor block in minutes, as reflected by the return of normal muscle strength in the innervation area of the respective nerve. This correlation will be expressed in min/ mm2.	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