Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

April 15, 2014 updated by: Robertas Martusevicius, Rigshospitalet, Denmark

Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency

The aim of this study is to determine the effect of epinephrine on systemic absorption of local anaesthetic mepivacaine administered for brachial plexus block in uremic patients scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

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:

  • patient acceptance of regional anaesthesia

Exclusion Criteria:

  • peripheral arteriosclerosis
  • diabetes mellitus
  • bleeding disorder
  • infection at the puncture site
  • allergy to mepivacaine
  • pregnancy

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Plain mepivacaine
Drug: Plain mepivacaine
Ultrasound-guided infraclavicular brachial plexus block with plain mepivacaine 400 mg (10 mg/mL)
Other Names:
  • Carbocain
Active Comparator: Mepivacaine with epinephrine
Drug: Mepivacaine with epinephrine
Ultrasound-guided infraclavicular brachial plexus block with mepivacaine 400 mg (10 mg/mL) mixed with epinephrine 200 μg (5 μg/mL)
Other Names:
  • Carbocain-Adrenalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of mepivacaine
Time Frame: 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade
0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central circulation
Time Frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade
Heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance
0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade
Peripheral tissue oxygenation
Time Frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade
Near infrared spectrometry obtained from the triceps muscle of the blocked arm
0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade
Cardiotoxicity of local anesthetic
Time Frame: 0, 5, 10, 20, 30, 45, and 60 min after blockade
12-lead ECG
0, 5, 10, 20, 30, 45, and 60 min after blockade
Neurotoxicity of local anesthetic
Time Frame: Continuously for 1 hour after blockade
Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity
Continuously for 1 hour after blockade

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Robertas Martusevicius, MD, Rigshospitalet, Denmark

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

September 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2011-154
  • 2012-000948-98 (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.

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