Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

NCT ID: NCT01533545

Last Updated: 2014-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Plain mepivacaine

Group Type ACTIVE_COMPARATOR

Plain mepivacaine

Intervention Type DRUG

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

Mepivacaine with epinephrine

Group Type ACTIVE_COMPARATOR

Mepivacaine with epinephrine

Intervention Type DRUG

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

Interventions

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Mepivacaine with epinephrine

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

Intervention Type DRUG

Plain mepivacaine

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

Intervention Type DRUG

Other Intervention Names

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Carbocain-Adrenalin Carbocain

Eligibility Criteria

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Inclusion Criteria

* patient acceptance of regional anaesthesia

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Robertas Martusevicius

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robertas Martusevicius, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 2914337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11122310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15966495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15635516 (View on PubMed)

Other Identifiers

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2012-000948-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-3-2011-154

Identifier Type: -

Identifier Source: org_study_id

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