Back to results

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

Primary Purpose

Infraclavicular Brachial Plexus Block

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Bupivacaine plus lidocaine

Bupivacaine 30 ml

About this trial

This is an interventional treatment trial for Infraclavicular Brachial Plexus Block focused on measuring Ultrasound guided infraclavicular brachial plexus block, Bupivacaine, Bupivacaine plus lidocaine, End stage renal disease, Arteriovenous fistula

Eligibility Criteria

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

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

Sites / Locations

Department of anesthesiology Siriraj Hospital Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bupivacaine plus lidocaine

Bupivacaine alone

Arm Description

Group 1: bupivacaine 20 ml plus lidocaine 10 ml

Group 2: bupivacaine 30 ml

Outcomes

Primary Outcome Measures

onset of sensory block

Secondary Outcome Measures

onset of motor block

Full Information

NCT ID

NCT00993746

First Posted

September 27, 2009

Last Updated

May 14, 2010

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00993746

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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?

6. Conditions and Keywords

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

Infraclavicular Brachial Plexus Block

Keywords

Ultrasound guided infraclavicular brachial plexus block, Bupivacaine, Bupivacaine plus lidocaine, End stage renal disease, Arteriovenous fistula

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bupivacaine plus lidocaine

Arm Type

Active Comparator

Arm Description

Group 1: bupivacaine 20 ml plus lidocaine 10 ml

Arm Title

Bupivacaine alone

Arm Type

Experimental

Arm Description

Group 2: bupivacaine 30 ml

Intervention Type

Drug

Intervention Name(s)

Bupivacaine plus lidocaine

Other Intervention Name(s)

Marcaine Xylocaine

Intervention Description

Bupivacaine 20 ml plus lidocaine 10 ml

Intervention Type

Drug

Intervention Name(s)

Bupivacaine 30 ml

Other Intervention Name(s)

lidocaine, marcaine

Intervention Description

Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block

Primary Outcome Measure Information:

Title

onset of sensory block

Time Frame

24 hour

Secondary Outcome Measure Information:

Title

onset of motor block

Time Frame

24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Orawan Pongraweewan, MD,FRCA

Phone

6681-4317599

pongraweewan@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orawan Pongrawewan, MD

Organizational Affiliation

Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of anesthesiology Siriraj Hospital Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs