Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

Not Applicable

Terminated

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: Plain mepivacaine; Drug: Mepivacaine with epinephrine

• Registration Number: NCT01533545
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Study Start: 2012-09
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-15
• Last Update Posted: 2014-04-16
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• patient acceptance of regional anaesthesia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain mepivacaine	Plain mepivacaine	-
Mepivacaine with epinephrine	Mepivacaine with epinephrine	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration of mepivacaine	0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade

Secondary Outcome Measures

Name	Time	Method
Central circulation	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	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	0, 5, 10, 20, 30, 45, and 60 min after blockade	12-lead ECG
Neurotoxicity of local anesthetic	Continuously for 1 hour after blockade	Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark