Arm InjuriesUS-SCBNCT01467596
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
A study testing Elderly population, Middle aged population in people with Arm Injuries and Anesthesia, run by Šarić, Jadranka Pavičić, M.D. at 2 sites in Croatia.
Trial summary
The aim of this study is to determine the minimum effective volume of local anesthetic (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for surgical anesthesia in 50% of patients and to calculate the effective volume required to produce an effective US-SCB in 95% of the… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Arm Injuries, Anesthesia
- What is being tested?
- Elderly population, Middle aged population
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesCroatia
- Study dates
- Nov 2011to Nov 2012
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 - 3 elderly patients (>65 years) scheduled for hand surgery
- ASA 1-3 middle aged patients (<45 years)
Who cannot join
- Cognitive impairment
- Coagulopathy
- Allergy to local anesthetics
- Infection at the puncture site,
- Body mass index > 35 kg/m2
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites
University Hospital Merkur
Zagreb, City of Zagreb, 10000
University Hospital Merkur
Zagreb, Croatia, 10000
About this study
Official title: Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB)
The aim of this study is to determine the minimum effective volume of local anesthetic (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for surgical anesthesia in 50% of patients and to calculate the effective volume required to produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group (>65 years) and in middle aged group (<45years) of patients.
Read the detailed description
We believe that known data regarding the minimum anesthetic volume required for effective US-SCB from middle age population can not be applicable to the elderly population since our preliminary data, presented at Euroanesthesia meeting in Amsterdam, 2011, and published in abstract form in the European Journal of Anaesthesiology, showed that involutional changes of brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial plexus at the first rib, allowed a 35% reduction in local anesthetic volume for an effective US-SCB for surgical anesthesia in elderly patients in comparison with the younger patients.
- Conditions
- Arm Injuries, Anesthesia
- Being tested
- Elderly population, Middle aged population
- Keywords
- Ultrasound, Brachial block, Levobupivacaine, Minimum, Volume, Minimum volume of Levobupivacaine 0,5%
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elderly population, Middle aged populationDevice
Also called Levobupivacaine 0.5%, Lidocaine 2%
The study method is a step-up/step-down sequence model where the dose of local anesthetic for the following patient is determined by the outcome of the preceding block. The starting dose of 50:50 mixture of 0.5% levobupivacaine and 2% lidocaine is 30 mL. In the case of block failure, the dose will be increased by 5 mL. Conversely, block success will result in a reduction in dose by 5 mL. A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous) at 5-min intervals up to 30 min after completion of US-SCB. Effective US-SCB will be defined as complete sensory blockade in the distribution of the radial, ulnar, median and musculocutaneous nerve.
| Study group | Role | What they receive |
|---|---|---|
| Elderly population | Experimental | MEAV50, MEAV95 Onset and duration of sensory and motor blockade Receives: Device: Elderly population, Middle aged population |
| Middle aged population | Active comparator | MEAV50, MEAV95 Onset and duration of sensory and motor blockade Receives: Device: Elderly population, Middle aged population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
Determining the minimum effective volume of a 50:50 mixture of levobupivacaine 0.5% and lidocaine 2% for successful supraclavicular brachial plexus block for hand surgery in 50% of elderly patients (MEAV50) and to calculate the effective volume in 95% of the elderly patients (MEAV95) as compared with control group (middle aged patients).
Measured: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes
Secondary outcomes (1)
Ultrasound-guided Supraclavicular Brachial Plexus Block in...
Sensory and motor block onset time and duration for each nerve (median, radial, ulnar and musculocutaneous) and for the group.
Measured: A blinded Assistant assess onset (in a 5-min intervals up to 30 minutes after completion of US-SCB) ) and duration of sensory and motor blockade (in a 30-min intervals after the completion of surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arm InjuriesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Šarić, Jadranka Pavičić, M.D.
- Responsible party
- Principal investigator, Jadranka Pavičić Šarić, Šarić, Jadranka Pavičić, M.D.
- Investigators
- Jadranka Pavičić Šarić, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467596
- Sponsor's protocol ID
- EudraCT 2011-005432-26
- Acronym
- US-SCB
- Status last verified
- Nov 2012
- First submitted
- 4 Nov 2011
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tomulic K, Pavicic Saric J, Acan I.Effect of age on anaesthetic volume for ultrasound guided supraclavicular brachial plexus block: 8AP2-8 June 2011 - Volume 28 - Issue - p 113 European Journal of Anaesthesiology
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB)
- ClinicalTrials.gov ID
- NCT01467596
- Acronym / sponsor ID
- US-SCB / EudraCT 2011-005432-26
- Conditions
- Arm Injuries, Anesthesia
- Keywords
- Ultrasound, Brachial block, Levobupivacaine, Minimum, Volume, Minimum volume of Levobupivacaine 0,5%
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Šarić, Jadranka Pavičić, M.D.
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Nov 2011 (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.
The aim of this study is to determine the minimum effective volume of local anesthetic (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for surgical anesthesia in 50% of patients and to calculate the effective volume required to produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group (>65 years) and in middle aged group (<45years) of patients.
Detailed description
We believe that known data regarding the minimum anesthetic volume required for effective US-SCB from middle age population can not be applicable to the elderly population since our preliminary data, presented at Euroanesthesia meeting in Amsterdam, 2011, and published in abstract form in the European Journal of Anaesthesiology, showed that involutional changes of brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial plexus at the first rib, allowed a 35% reduction in local anesthetic volume for an effective US-SCB for surgical anesthesia in elderly patients in comparison with the younger patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly population | Experimental | Device: Elderly population, Middle aged populationMEAV50, MEAV95 Onset and duration of sensory and motor blockade |
| Middle aged population | Active comparator | Device: Elderly population, Middle aged populationMEAV50, MEAV95 Onset and duration of sensory and motor blockade |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1 - 3 elderly patients (>65 years) scheduled for hand surgery
- ASA 1-3 middle aged patients (<45 years)
Key exclusion criteria (5 listed)
- Cognitive impairment
- Coagulopathy
- Allergy to local anesthetics
- Infection at the puncture site,
- Body mass index > 35 kg/m2
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 |
|---|---|---|
| Elderly population, Middle aged populationAlso: Levobupivacaine 0.5%, Lidocaine 2%The study method is a step-up/step-down sequence model where the dose of local anesthetic for the following patient is determined by the outcome of the preceding block. The starting dose of 50:50 mixture of 0.5% levobupivacaine and 2% lidocaine is 30 mL. In the case of block failure, the dose will be increased by 5 mL. Conversely, block success will result in a reduction in dose by 5 mL. A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous) at 5-min intervals up to 30 min after completion of US-SCB. Effective US-SCB will be defined as complete sensory blockade in the distribution of the radial, ulnar, median and musculocutaneous nerve. | Device | Elderly population, Middle aged population |
Primary outcome
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
Time frame: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes
Determining the minimum effective volume of a 50:50 mixture of levobupivacaine 0.5% and lidocaine 2% for successful supraclavicular brachial plexus block for hand surgery in 50% of elderly patients (MEAV50) and to calculate the effective volume in 95% of the elderly patients (MEAV95) as compared with control group (middle aged patients).
1 secondary outcome
Ultrasound-guided Supraclavicular Brachial Plexus Block in...
Time frame: A blinded Assistant assess onset (in a 5-min intervals up to 30 minutes after completion of US-SCB) ) and duration of sensory and motor blockade (in a 30-min intervals after the completion of surgery).
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 15 Nov 2012.
- Results publicationTomulic K, Pavicic Saric J, Acan I.Effect of age on anaesthetic volume for ultrasound guided supraclavicular brachial plexus block: 8AP2-8 June 2011 - Volume 28 - Issue - p 113 European Journal of Anaesthesiology
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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.
Jadranka Pavičić Šarić, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elderly population, Middle aged population in people with Arm Injuries and Anesthesia, run by Šarić, Jadranka Pavičić, M.D. at 2 sites in Croatia.
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 2 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 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. 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?
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly (time frame: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467596, which also lists 1 linked publication.
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 15 Nov 2012.