Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Insufficiency, Chronic
Intervention: Mepivacaine with epinephrine (Drug); Plain mepivacaine (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Rigshospitalet, Denmark Official(s) and/or principal investigator(s): Robertas Martusevicius, MD, Principal Investigator, Affiliation: Rigshospitalet, Denmark
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.
Clinical Details
Official title: Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Plasma concentration of mepivacaine
Secondary outcome: Central circulationPeripheral tissue oxygenation Cardiotoxicity of local anesthetic Neurotoxicity of local anesthetic
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rigshospitalet, Copenhagen 2100, Denmark
Additional Information
Information about Mepivacaine from Danish Medicines Agency (in Danish)
Related publications: 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. Norio K, Mäkisalo 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. Niemi G. Advantages and disadvantages of adrenaline in regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):229-45. Review. 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. Review.
Starting date: September 2012
Last updated: April 15, 2014
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