Infraclavicular Brachial Plexus BlockPhase 4NCT00993746
2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula
A Phase 4 study testing Bupivacaine plus lidocaine and Bupivacaine 30 ml in people with Infraclavicular Brachial Plexus Block, run by Mahidol University at 1 site in Thailand.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infraclavicular Brachial Plexus Block
- What is being tested?
- Bupivacaine plus lidocaine and Bupivacaine 30 ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESRD patient for AVF procedure
- age >17 year
- BMI 20-35 kg/m2
- communicable
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of anesthesiology Siriraj Hospital Mahidol University
Bangkok, 10700
About this study
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
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?
- Conditions
- Infraclavicular Brachial Plexus Block
- Being tested
- Bupivacaine plus lidocaine, Bupivacaine 30 ml
- Keywords
- Ultrasound guided infraclavicular brachial plexus block, Bupivacaine, Bupivacaine plus lidocaine, End stage renal disease, Arteriovenous fistula
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine plus lidocaineDrug
Also called Marcaine Xylocaine
Bupivacaine 20 ml plus lidocaine 10 ml
Bupivacaine 30 mlDrug
Also called lidocaine, marcaine
Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine plus lidocaine | Active comparator | Group 1: bupivacaine 20 ml plus lidocaine 10 ml Receives: Drug: Bupivacaine plus lidocaine |
| Bupivacaine alone | Experimental | Group 2: bupivacaine 30 ml Receives: Drug: Bupivacaine 30 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset of sensory block
Measured: 24 hour
Secondary outcomes (1)
onset of motor block
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infraclavicular Brachial Plexus BlockStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Orawan Pongrawewan, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993746
- Sponsor's protocol ID
- si433/2009
- Status last verified
- Oct 2009
- First submitted
- 27 Sep 2009
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00993746
- Acronym / sponsor ID
- si433/2009
- Conditions
- Infraclavicular Brachial Plexus Block
- Keywords
- Ultrasound guided infraclavicular brachial plexus block, Bupivacaine, Bupivacaine plus lidocaine, End stage renal disease, Arteriovenous fistula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine plus lidocaine | Active comparator | Drug: Bupivacaine plus lidocaineGroup 1: bupivacaine 20 ml plus lidocaine 10 ml |
| Bupivacaine alone | Experimental | Drug: Bupivacaine 30 mlGroup 2: bupivacaine 30 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ESRD patient for AVF procedure
- age >17 year
- BMI 20-35 kg/m2
- communicable
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine plus lidocaineAlso: Marcaine XylocaineBupivacaine 20 ml plus lidocaine 10 ml | Drug | Bupivacaine plus lidocaine |
| Bupivacaine 30 mlAlso: lidocaine, marcaineBupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block | Drug | Bupivacaine alone |
Primary outcome
onset of sensory block
Time frame: 24 hour
1 secondary outcome
onset of motor block
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orawan Pongrawewan, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine plus lidocaine and Bupivacaine 30 ml in people with Infraclavicular Brachial Plexus Block, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orawan Pongraweewan, MD,FRCA (6681-4317599, pongraweewan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset of sensory block (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2010.