2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by Mahidol University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Mahidol University

ClinicalTrials.gov Identifier:

NCT00993746

First received: September 27, 2009

Last updated: May 14, 2010

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2009

Last Updated Date

May 14, 2010

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

onset of sensory block [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00993746 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

onset of motor block [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula

Official Title ^ICMJE

Comparison of Onset of Action Between 2% Lidocaine Plus 0.5% Bupivacaine and 0.5% Bupivacaine in Brachial Plexus Anesthesia for Creation of Arteriovenous Fistula in ESRD Patient

Brief Summary

Will the technique of adding lidocaine to bupivacaine fasten the onset of bupivacaine alone for infraclavicular brachial plexus block in end-stage renal disease (ESRD) patient?

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Infraclavicular Brachial Plexus Block

Intervention ^ICMJE

Drug: Bupivacaine plus lidocaine
Bupivacaine 20 ml plus lidocaine 10 ml

Other Name: Marcaine Xylocaine
Drug: Bupivacaine 30 ml
Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block

Other Name: lidocaine, marcaine

Study Arm (s)

Active Comparator: Bupivacaine plus lidocaine
Group 1: bupivacaine 20 ml plus lidocaine 10 ml

Intervention: Drug: Bupivacaine plus lidocaine
Experimental: Bupivacaine alone
Group 2: bupivacaine 30 ml

Intervention: Drug: Bupivacaine 30 ml

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2011

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

ESRD patient for AVF procedure
age >17 year
BMI 20-35 kg/m2
communicable

Exclusion Criteria:

BMI > 35 kg/m2 BMI < 20 kg/m2 หรือ BW < 35 kg
History of allergy to local anesthetic drugs
Pre-operative neurological deficit, Neuromuscular disorder หรือ old CVA
Psychiatric disorder
Coagulation disorder
Uncontrolled seizure
Pregnant and lactating women

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Orawan Pongraweewan, MD,FRCA

6681-4317599

pongraweewan@yahoo.com

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT00993746

Other Study ID Numbers ^ICMJE

si433/2009

Has Data Monitoring Committee

Responsible Party

Faculty of Medicine Siriraj Hospital, Mahidol University

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Orawan Pongrawewan, MD

Siriraj Hospital

Information Provided By

Mahidol University

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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