Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01533545
• Other study ID #: H-3-2011-154
• Secondary ID: 2012-000948-98
• Status: Terminated
• Phase: N/A
• First received: February 8, 2012
• Last updated: April 15, 2014
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Mepivacaine with epinephrine
Ultrasound-guided infraclavicular brachial plexus block with mepivacaine 400 mg (10 mg/mL) mixed with epinephrine 200 µg (5 µg/mL)
• Plain mepivacaine
Ultrasound-guided infraclavicular brachial plexus block with plain mepivacaine 400 mg (10 mg/mL)

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

Niemi G. Advantages and disadvantages of adrenaline in regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):229-45. Review. — View Citation

Norio K, Mäkisalo 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of mepivacaine		0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade	Yes
Secondary	Central circulation	Heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance	0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade	Yes
Secondary	Peripheral tissue oxygenation	Near infrared spectrometry obtained from the triceps muscle of the blocked arm	0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade	Yes
Secondary	Cardiotoxicity of local anesthetic	12-lead ECG	0, 5, 10, 20, 30, 45, and 60 min after blockade	Yes
Secondary	Neurotoxicity of local anesthetic	Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity	Continuously for 1 hour after blockade	Yes

External Links

•   Information about Mepivacaine from Danish Medicines Agency (in Danish)