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

NCT01603680 | Completed Phase 4 DMC

• 2 other identifiers: ArAL 11.12011-002608-34
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia

Keywords

Ultrasonography; Block nerve; Anaesthesia; Carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• Efficacy and onset of action

  Sensory block will be assessed as a loss of cold sensation elicited by a cold wet cotton swab in the areas of the medial and ulnar nerves by comparison with contralateral hand. Sensory block will be clasiffied as follows: 0, anesthesia; 1, hyposthesia; 2, normal sensation. Motor function will be tested as according to a modified Bromage score: 0, no motor blokade; 1, weak response against resistence; 2, complete motor blockade. Motor and sensory blockades will be assessed by a blinded observer at 5, 15, 30 mins after local anesthetic injection and on arrival in the recovery room.

  On arrival in the recovery room

Secondary Outcomes (1)

• Complications in postoperative time

  24 hours postoperative time

Study Arms (2)

Circumferential (C)

OTHER

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

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

Non circumferential (NC)

OTHER

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

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

Interventions

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

Also known as: Local anesthetic spread, "Doughnut sign"

Circumferential (C)

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

Also known as: Asymmetric local anesthetic spread

Non circumferential (NC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Complexo Hospitalario Universitario de A Coruña: lead

Study Sites (1)

Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago

A Coruña, A Coruña, 15006, Spain

Location

Related Publications (3)

• 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.

  PMID: 20650379 RESULT

• 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.

  PMID: 20975475 RESULT

• 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.

  PMID: 32165554 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Paula Diéguez, Anesthetist

  Complexo Hospitalario Universitario A Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: May 22, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

ES (1)