Renal Insufficiency, Chronic Clinical Trial
Official title:
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.
Status | Terminated |
Enrollment | 16 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patient acceptance of regional anaesthesia Exclusion Criteria: - peripheral arteriosclerosis - diabetes mellitus - bleeding disorder - infection at the puncture site - allergy to mepivacaine - pregnancy |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
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. — View Citation
Niemi G. Advantages and disadvantages of adrenaline in regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):229-45. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentration of mepivacaine | 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade | Yes | |
Secondary | Central circulation | Heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance | 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade | Yes |
Secondary | Peripheral tissue oxygenation | Near infrared spectrometry obtained from the triceps muscle of the blocked arm | 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade | Yes |
Secondary | Cardiotoxicity of local anesthetic | 12-lead ECG | 0, 5, 10, 20, 30, 45, and 60 min after blockade | Yes |
Secondary | Neurotoxicity of local anesthetic | Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity | Continuously for 1 hour after blockade | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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