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

August 3, 2015 updated by: Paula Diéguez García, Complexo Hospitalario Universitario de A Coruña

Circumferential Versus Not Circumferential Distribution of Mepivacaine Around the Median and Ulnar Nerves in the Carpal Tunnel Surgery. Randomized Clinical Trial, Double Blinded.

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Complexo Hospitalario Universitario A Coruña. Hospital Abente y Lago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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"
Other: 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 Names:
  • Asymmetric local anesthetic spread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy and onset of action
Time Frame: On arrival in the recovery room
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications in postoperative time
Time Frame: 24 hours postoperative time
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)
24 hours postoperative time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complexo Hospitalario Universitario de A Coruña

Investigators

  • Principal Investigator: Paula Diéguez, Anesthetist, Complexo Hospitalario Universitario A Coruña

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

May 20, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArAL 11.1
  • 2011-002608-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe