Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Robertas Martusevicius, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01533545
First received: February 8, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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 Intervention
Renal Insufficiency, Chronic
Drug: Mepivacaine with epinephrine
Drug: Plain mepivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Plasma concentration of mepivacaine [ Time Frame: 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Central circulation [ Time Frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade ] [ Designated as safety issue: Yes ]
    Heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance

  • Peripheral tissue oxygenation [ Time Frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade ] [ Designated as safety issue: Yes ]
    Near infrared spectrometry obtained from the triceps muscle of the blocked arm

  • Cardiotoxicity of local anesthetic [ Time Frame: 0, 5, 10, 20, 30, 45, and 60 min after blockade ] [ Designated as safety issue: Yes ]
    12-lead ECG

  • Neurotoxicity of local anesthetic [ Time Frame: Continuously for 1 hour after blockade ] [ Designated as safety issue: Yes ]
    Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity


Enrollment: 16
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

Inclusion Criteria:

  • patient acceptance of regional anaesthesia

Exclusion Criteria:

  • peripheral arteriosclerosis
  • diabetes mellitus
  • bleeding disorder
  • infection at the puncture site
  • allergy to mepivacaine
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533545

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Robertas Martusevicius, MD Rigshospitalet, Denmark
  More Information

Additional Information:
Publications:
Responsible Party: Robertas Martusevicius, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01533545     History of Changes
Other Study ID Numbers: H-3-2011-154, 2012-000948-98
Study First Received: February 8, 2012
Last Updated: April 15, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Mepivacaine
Epinephrine
Brachial plexus block
Renal insufficiency

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Mepivacaine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 20, 2014