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

This study is currently recruiting participants.
Verified May 2012 by Complexo Hospitalario Universitario de A Coruña
Sponsor:
Information provided by (Responsible Party):
Paula Diéguez García, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier:
NCT01603680
First received: January 16, 2012
Last updated: May 20, 2012
Last verified: May 2012
History of Changes
  Purpose
  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.

Condition Intervention Phase
Anesthesia
 Procedure: Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow
Procedure: Non circumferential spread in ultrasound-guided median and ulnar nerves block
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Circumferential Versus Not Circumferential Distribution of Mepivacaine Around the Median and Ulnar Nerves in the Carpal Tunnel Surgery. Randomized Clinical Trial, Double Blinded.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Complexo Hospitalario Universitario de A Coruña:

Primary Outcome Measures:
  • Efficacy and onset of action [ Time Frame: On arrival in the recovery room ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Complications in postoperative time [ Time Frame: 24 hours postoperative time ] [ Designated as safety issue: Yes ]
    Since the nerve block to the hospital outcome will be registered potencial block-related complications. At the first postoperative day, each patient will be called by phone, to report the time at first onset of pain in the operative site and lack of residual postoperative neurologic symptoms, postoperative nausea and vomiting, and hospital readmission (for severity of pain or bleeding or other reasons)


Estimated Enrollment: 124
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Procedure: 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
Other Names:
  • Local anesthetic spread
  • "Doughnut sign"
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
 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
Other Name: Asymmetric local anesthetic spread

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled patients for surgery of carpal tunnel including patients in ASA I-III status, without exclusion criteria. The principal investigator study and/or other designated site staff will obtain written informed consent from all research patients.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603680

Contacts
Contact: Paula Diéguez, Anesthetist 981176380 ext 291459 pauladieguez@yahoo.com

Locations
Spain
Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago Recruiting
A Coruña, Spain, 15006
Contact: Hospital Abente y Lago, Anesthetist     981176380 ext 291459     pauladieguez@yahoo.com    
Principal Investigator: Paula Diéguez, Anesthetist            
Sponsors and Collaborators
Complexo Hospitalario Universitario de A Coruña
Investigators
Principal Investigator: Paula Diéguez, Anesthetist Complexo Hospitalario Universitario A Coruña
  More Information

Publications:

Responsible Party: Paula Diéguez García, Principal Investigator, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier: NCT01603680     History of Changes
Other Study ID Numbers: ArAL 11.1, 2011-002608-34
Study First Received: January 16, 2012
Last Updated: May 20, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Complexo Hospitalario Universitario de A Coruña:
Ultrasonography
Block nerve
Anaesthesia
Carpal tunnel syndrome

Additional relevant MeSH terms:
Anesthetics, Local
Mepivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013