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Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

Primary Purpose

Renal Insufficiency, Chronic

Status

Terminated

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Mepivacaine with epinephrine

Plain mepivacaine

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Mepivacaine, Epinephrine, Brachial plexus block, Renal insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patient acceptance of regional anaesthesia

Exclusion Criteria:

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

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Plain mepivacaine

Mepivacaine with epinephrine

Arm Description

Outcomes

Primary Outcome Measures

Plasma concentration of mepivacaine

Secondary Outcome Measures

Central circulation

Heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance

Peripheral tissue oxygenation

Near infrared spectrometry obtained from the triceps muscle of the blocked arm

Cardiotoxicity of local anesthetic

12-lead ECG

Neurotoxicity of local anesthetic

Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity

Full Information

NCT ID

NCT01533545

First Posted

February 8, 2012

Last Updated

April 15, 2014

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01533545

Brief Title

Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

Official Title

Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Slow recruitment

Study Start Date

September 2012 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Chronic

Keywords

Mepivacaine, Epinephrine, Brachial plexus block, Renal insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plain mepivacaine

Arm Type

Active Comparator

Arm Title

Mepivacaine with epinephrine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Mepivacaine with epinephrine

Other Intervention Name(s)

Carbocain-Adrenalin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Plain mepivacaine

Other Intervention Name(s)

Carbocain

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma concentration of mepivacaine

Time Frame

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

Secondary Outcome Measure Information:

Title

Central circulation

Description

Heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance

Time Frame

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

Title

Peripheral tissue oxygenation

Description

Near infrared spectrometry obtained from the triceps muscle of the blocked arm

Time Frame

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

Title

Cardiotoxicity of local anesthetic

Description

12-lead ECG

Time Frame

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

Title

Neurotoxicity of local anesthetic

Description

Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity

Time Frame

Continuously for 1 hour after blockade

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patient acceptance of regional anaesthesia Exclusion Criteria: peripheral arteriosclerosis diabetes mellitus bleeding disorder infection at the puncture site allergy to mepivacaine pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robertas Martusevicius, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

2914337

Citation

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.

Results Reference

background

PubMed Identifier

11122310

Citation

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.

Results Reference

background

PubMed Identifier

15966495

Citation

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.

Results Reference

background

PubMed Identifier

15635516

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. doi: 10.1016/j.rapm.2004.08.003.

Results Reference

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Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

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