Distribution Circumferential Versus Non Circumferential of Mepivacaine in the Median and Ulnar Nerves

NCT ID: NCT01603680

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-07-31

Brief Summary

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1. Evaluation of the efficacy of the circumferential versus non circumferential distribution of mepivacaine around the median and ulnar nerves.
2. Evaluation the onset of action of mepivacaine in circumferential versus non circumferential distribution around the median and ulnar nerves.
3. Spread of mepivacaine after injection guided by ultrasonography.
4. Complications of both anesthetic techniques in postoperative time.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Circumferential (C)

"Circumferential"(C) spread group will be defined as mepivacaine injectate visualized by ultrasonography all around the median and ulnar nerves imaged in short axis.

Group Type OTHER

Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow

Intervention Type PROCEDURE

Homogeneous spread of 6 ml of mepivacaine 1% around the median and ulnar nerves in each one using several needle passes and active hydrodissection

Non circumferential (NC)

Local anesthetic spread will be asymmetrical around the median and ulnar nerves, the mepivacaine will be partially in contact with the nerve

Group Type OTHER

Non circumferential spread in ultrasound-guided median and ulnar nerves block

Intervention Type PROCEDURE

Asymmetric spread of 6 ml of mepivacaine 1% in contact with median and ulnar nerves block in each one, using only one needle pass

Interventions

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Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow

Homogeneous spread of 6 ml of mepivacaine 1% around the median and ulnar nerves in each one using several needle passes and active hydrodissection

Intervention Type PROCEDURE

Non circumferential spread in ultrasound-guided median and ulnar nerves block

Asymmetric spread of 6 ml of mepivacaine 1% in contact with median and ulnar nerves block in each one, using only one needle pass

Intervention Type PROCEDURE

Other Intervention Names

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Local anesthetic spread "Doughnut sign" Asymmetric local anesthetic spread

Eligibility Criteria

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Exclusion Criteria

* Abnormal bleeding, infection in the punction side, allergy or other problems with the medication of the study, muscular or nerve diseases, patients \< 18 years old, pregnancy, cognitive disease or reject of the patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Complexo Hospitalario Universitario de A Coruña

OTHER

Sponsor Role lead

Responsible Party

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Paula Diéguez García

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paula Diéguez, Anesthetist

Role: PRINCIPAL_INVESTIGATOR

Complexo Hospitalario Universitario A Coruña

Locations

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Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago

A Coruña, A Coruña, Spain

Site Status

Countries

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Spain

References

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Al-Nasser B, Hubert C, Negre M. Role of local anesthetic spread pattern and electrical stimulation in ultrasound-guided musculocutaneous nerve block. J Clin Anesth. 2010 Aug;22(5):334-9. doi: 10.1016/j.jclinane.2009.09.008.

Reference Type RESULT
PMID: 20650379 (View on PubMed)

Morau D, Levy F, Bringuier S, Biboulet P, Choquet O, Kassim M, Bernard N, Capdevila X. Ultrasound-guided evaluation of the local anesthetic spread parameters required for a rapid surgical popliteal sciatic nerve block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):559-64. doi: 10.1097/AAP.0b013e3181fa6b60.

Reference Type RESULT
PMID: 20975475 (View on PubMed)

Dieguez-Garcia P, Lopez-Alvarez S, Juncal J, Lopez AM, Sala-Blanch X. Comparison of the effectiveness of circumferential versus non-circumferential spread in median and ulnar nerve blocks. A double-blind randomized clinical trial. Reg Anesth Pain Med. 2020 May;45(5):362-366. doi: 10.1136/rapm-2019-101157. Epub 2020 Mar 11.

Reference Type DERIVED
PMID: 32165554 (View on PubMed)

Other Identifiers

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2011-002608-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ArAL 11.1

Identifier Type: -

Identifier Source: org_study_id

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