NCT01533545

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

February 8, 2012

Last Update Submit

April 15, 2014

Conditions

Renal Insufficiency, Chronic

Keywords

MepivacaineEpinephrineBrachial plexus blockRenal insufficiency

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of mepivacaine

    0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade

Secondary Outcomes (4)

  • Central circulation

    0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade

  • Peripheral tissue oxygenation

    0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade

  • Cardiotoxicity of local anesthetic

    0, 5, 10, 20, 30, 45, and 60 min after blockade

  • Neurotoxicity of local anesthetic

    Continuously for 1 hour after blockade

Study Arms (2)

Plain mepivacaine

ACTIVE COMPARATOR
Drug: Plain mepivacaine

Mepivacaine with epinephrine

ACTIVE COMPARATOR
Drug: Mepivacaine with epinephrine

Interventions

Mepivacaine with epinephrineDRUG

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

Also known as: Carbocain-Adrenalin
Mepivacaine with epinephrine
Plain mepivacaineDRUG

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

Also known as: Carbocain
Plain mepivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient acceptance of regional anaesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 2914337BACKGROUND

  • 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.

    PMID: 11122310BACKGROUND

  • 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.

    PMID: 15966495BACKGROUND

  • 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.

    PMID: 15635516BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicRenal Insufficiency

Interventions

MepivacaineEpinephrine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Robertas Martusevicius, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 15, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations

DK(1)