Hand SurgeryNCT00699244
Comparison of Central Versus Peripheral Placement of Local Anesthetic
A study testing Peripheral placement of local anesthesia and Central placement of local anesthesia in people with Hand Surgery and Elbow Surgery, run by Vanderbilt University at 1 site in United States.
Trial summary
Does ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Surgery, Elbow Surgery, Forearm Surgery
- What is being tested?
- Peripheral placement of local anesthesia and Central placement of local anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Mar 2009
- Phase
- Interventional
- 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
- American Society of Anesthesiologists (ASA) Class I-III.
- Patient is undergoing elective hand or forearm surgery.
- Patient is an adult, 18 years old or older.
Who cannot join
- Morbid obesity (calculated body mass index > 35 kg/m2).
- Patient unable to cooperate.
- Patient with a known brachial plexus injury.
- Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder).
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Orthopedic Surgicenter
Nashville, Tennessee, 37212
About this study
Official title: Selective Local Anesthetic Placement Using Ultrasound-guidance and Neurostimulation for the Infraclavicularbrachial Plexus Block
Does ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.
Read the detailed description
A comparison of the infraclavicular placement of local anesthetic either centrally (posterior cord) vs peripheral placement (lateral or medial cord) using ultrasound guidance. This will be done to determine if ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.
- Conditions
- Hand Surgery, Elbow Surgery, Forearm Surgery, Wrist Surgery
- Being tested
- Peripheral placement of local anesthesia, Central placement of local anesthesia
- Keywords
- forearm, hand, elbow, wrist, brachial plexus, infraclavicular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral placement of local anesthesiaProcedure or surgery
Peripheral placement of local anesthesia
Central placement of local anesthesiaProcedure or surgery
Central placement of local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Peripheral placement of local anesthesia | Experimental | to receive ultrasound guided peripheral placement of local anesthetic Receives: Procedure: Peripheral placement of local anesthesia |
| Central placement of local anesthesia | Active comparator | to receive central placement of local anesthetic Receives: Procedure: Central placement of local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase success rate of the block to produce surgical anesthesia and analgesia
Measured: during and following surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startDec 2006
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand SurgeryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clifford Bowens, Vanderbilt University
- Investigators
- Clifford Bowens, M.D., Principal investigator, clifford.bowens@vanderbilt.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699244
- Sponsor's protocol ID
- 61267
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2008
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Local Anesthetic Placement Using Ultrasound-guidance and Neurostimulation for the Infraclavicularbrachial Plexus Block
- ClinicalTrials.gov ID
- NCT00699244
- Acronym / sponsor ID
- 61267
- Conditions
- Hand Surgery, Elbow Surgery, Forearm Surgery, Wrist Surgery
- Keywords
- forearm, hand, elbow, wrist, brachial plexus, infraclavicular block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Jun 2008 (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.
Does ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.
Detailed description
A comparison of the infraclavicular placement of local anesthetic either centrally (posterior cord) vs peripheral placement (lateral or medial cord) using ultrasound guidance. This will be done to determine if ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral placement of local anesthesia | Experimental | Procedure: Peripheral placement of local anesthesiato receive ultrasound guided peripheral placement of local anesthetic |
| Central placement of local anesthesia | Active comparator | Procedure: Central placement of local anesthesiato receive central placement of local anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) Class I-III.
- Patient is undergoing elective hand or forearm surgery.
- Patient is an adult, 18 years old or older.
Key exclusion criteria (5 listed)
- Morbid obesity (calculated body mass index > 35 kg/m2).
- Patient unable to cooperate.
- Patient with a known brachial plexus injury.
- Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder).
- Patients who are pregnant.
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 |
|---|---|---|
| Peripheral placement of local anesthesiaPeripheral placement of local anesthesia | Procedure or surgery | Peripheral placement of local anesthesia |
| Central placement of local anesthesiaCentral placement of local anesthesia | Procedure or surgery | Central placement of local anesthesia |
Primary outcome
increase success rate of the block to produce surgical anesthesia and analgesia
Time frame: during and following surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Vanderbilt University Medical Center Department of AnesthesiologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Clifford Bowens, M.D. principal investigator
clifford.bowens@vanderbilt.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral placement of local anesthesia and Central placement of local anesthesia in people with Hand Surgery and Elbow Surgery, run by Vanderbilt University at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jun 2017. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase success rate of the block to produce surgical anesthesia and analgesia (time frame: during and following surgical procedure). 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 12 Jun 2017.