Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533545
Recruitment Status : Terminated (Slow recruitment)
First Posted : February 15, 2012
Last Update Posted : April 16, 2014
Information provided by (Responsible Party):
Robertas Martusevicius, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Drug: Mepivacaine with epinephrine Drug: Plain mepivacaine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency
Study Start Date : September 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

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 Name: 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 Name: Carbocain-Adrenalin

Primary Outcome Measures :
  1. Plasma concentration of mepivacaine [ Time Frame: 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Cardiotoxicity of local anesthetic [ Time Frame: 0, 5, 10, 20, 30, 45, and 60 min after blockade ]
    12-lead ECG

  4. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient acceptance of regional anaesthesia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01533545

Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Robertas Martusevicius, MD Rigshospitalet, Denmark

Responsible Party: Robertas Martusevicius, Principal Investigator, Rigshospitalet, Denmark Identifier: NCT01533545     History of Changes
Other Study ID Numbers: H-3-2011-154
2012-000948-98 ( EudraCT Number )
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014

Keywords provided by Robertas Martusevicius, Rigshospitalet, Denmark:
Brachial plexus block
Renal insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents