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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01533545
Enrollment
16
Registered
2012-02-15
Start date
2012-09-30
Completion date
2014-09-30
Last updated
2014-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency, Chronic

Keywords

Mepivacaine, Epinephrine, Brachial plexus block, Renal insufficiency

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.

Interventions

DRUGMepivacaine with epinephrine

Ultrasound-guided infraclavicular brachial plexus block with mepivacaine 400 mg (10 mg/mL) mixed with epinephrine 200 μg (5 μg/mL)

DRUGPlain mepivacaine

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

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient acceptance of regional anaesthesia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Plasma concentration of mepivacaine0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade

Secondary

MeasureTime frameDescription
Central circulation0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockadeHeart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance
Peripheral tissue oxygenation0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockadeNear infrared spectrometry obtained from the triceps muscle of the blocked arm
Cardiotoxicity of local anesthetic0, 5, 10, 20, 30, 45, and 60 min after blockade12-lead ECG
Neurotoxicity of local anestheticContinuously for 1 hour after blockadeVisual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026