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Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

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ClinicalTrials.gov Identifier: NCT01533545
Recruitment Status : Terminated (Slow recruitment)
First Posted : February 15, 2012
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Robertas Martusevicius, Rigshospitalet, Denmark

February 8, 2012
February 15, 2012
April 16, 2014
September 2012
September 2014   (Final data collection date for primary outcome measure)
Plasma concentration of mepivacaine [ Time Frame: 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade ]
Same as current
Complete list of historical versions of study NCT01533545 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • Cardiotoxicity of local anesthetic [ Time Frame: 0, 5, 10, 20, 30, 45, and 60 min after blockade ]
    12-lead ECG
  • 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
  • Central circulation [ Time Frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade ]
    Noninvasive arterial blood pressure and cardiac output
  • 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
Not Provided
Not Provided
 
Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Renal Insufficiency, Chronic
  • 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
  • Drug: Plain mepivacaine
    Ultrasound-guided infraclavicular brachial plexus block with plain mepivacaine 400 mg (10 mg/mL)
    Other Name: Carbocain
  • Active Comparator: Plain mepivacaine
    Intervention: Drug: Plain mepivacaine
  • Active Comparator: Mepivacaine with epinephrine
    Intervention: Drug: Mepivacaine with epinephrine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
36
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patient acceptance of regional anaesthesia

Exclusion Criteria:

  • peripheral arteriosclerosis
  • diabetes mellitus
  • bleeding disorder
  • infection at the puncture site
  • allergy to mepivacaine
  • pregnancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01533545
H-3-2011-154
2012-000948-98 ( EudraCT Number )
Yes
Not Provided
Not Provided
Robertas Martusevicius, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Robertas Martusevicius, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP