Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

Overview

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.

Full Title of Study: “Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: September 2014

Interventions

  • 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)
  • Drug: Plain mepivacaine
    • Ultrasound-guided infraclavicular brachial plexus block with plain mepivacaine 400 mg (10 mg/mL)

Arms, Groups and Cohorts

  • Active Comparator: Plain mepivacaine
  • Active Comparator: Mepivacaine with epinephrine

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • patient acceptance of regional anaesthesia Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robertas Martusevicius, Principal Investigator – Rigshospitalet, Denmark
  • Overall Official(s)
    • Robertas Martusevicius, MD, Principal Investigator, Rigshospitalet, Denmark

References

McEllistrem RF, Schell J, O'Malley K, O'Toole D, Cunningham AJ. Interscalene brachial plexus blockade with lidocaine in chronic renal failure–a pharmacokinetic study. Can J Anaesth. 1989 Jan;36(1):59-63. doi: 10.1007/BF03010889.

Norio K, Makisalo H, Isoniemi H, Groop PH, Pere P, Lindgren L. Are diabetic patients in danger at renal transplantation? An invasive perioperative study. Eur J Anaesthesiol. 2000 Dec;17(12):729-36. doi: 10.1046/j.1365-2346.2000.00760.x.

Niemi G. Advantages and disadvantages of adrenaline in regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):229-45. doi: 10.1016/j.bpa.2004.12.004.

Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.

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