Axillary Brachial Plexus BlockNCT01421914
Determining the Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Axillary Brachial Plexus Block
A study testing Bupivacaine 0,5% in people with Axillary Brachial Plexus Block, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This is a study to calculate the minimum effective volume of bupivacaine 0,5% with epinephrine for successful axillary brachial plexus block for hand surgery in 50% of the patients (MEV50). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axillary Brachial Plexus Block
- What is being tested?
- Bupivacaine 0,5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2010to Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 and 2 adult patients scheduled for ambulatorial hand surgery were included
Who cannot join
- cognitive impairment,
- coagulopathy,
- allergy to bupivacaine,
- infection at the puncture site,
- body mass index > 35 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
This is a study to calculate the minimum effective volume of bupivacaine 0,5% with epinephrine for successful axillary brachial plexus block for hand surgery in 50% of the patients (MEV50).
Read the detailed description
Study Design All patients had their demographic data recorded upon inclusion in the study. Routine preoperative monitoring was subsequently performed using ECG, non-invasive blood pressure measurements and pulse oximetry. Intravenous access was established and maintained with a crystalloid infusion.
The axillary approach using ultrasound (M-Turbo ® System with HFL 38x linear transducer 13-6 MHz, SonoSite, Bothell, WA, USA) and peripheral nerve stimulation (Stimuplex ® DIG RC, B. Braun, Melsung, Germany) guidance was performed to obtain brachial plexus block with the patient lying in the supine position. The needle used was a 22G x 50 mm (AEQ2250, BMD Group, Venezia, Italy). The puncture site was infiltrated with lidocaine 1% after asepsis and antisepsis skin treatment with chlorhexidine. After that, the ulnar, radial, median and musculocutaneous nerves were visualized by ultrasound (Figure 1) and had their identity confirmed by nerve stimulation. An initial dose of 5 mL of bupivacaine 0.5% with adrenaline (1:200,000) was injected in the proximity of each nerve. If severe pain at the injection was referred or, if nerve diameter changed during injection, injection was immediately interrupted, patient was removed form study and followed postoperatively for possible intraneural injection. The needle was repositioned during injection and perineural injected was ensured by ultrasound.
The efficacy of the block was assessed by an assessor blinded to injected volume. Assessments were conducted every 5 min up to a total of 30 min following the end of the injection of the local anaesthetic. Block assessment was finished either after surgical anaesthesia was achieved or,after 30 min had elapsed.
Success or failure of the block was used to dynamically reduce or increase, respectively, the volume of local anaesthetic that was used for the subsequent patient. When a block was achieved, the subsequent patient received a 0.5 mL reduction in the total volume of local anaesthetic per nerve. Upon failure of the block, the patient received a complementation of nerve blocks at a point distal to the axilla, and the volume of local anaesthetic delivered to the next patient was increased by 0.5 mL. After the block was assessed, the patients were cleared for surgery. During surgery, an infusion of 25-50 mcg.kg-1.min-1 of propofol was used to achieve proper sedation. Also, if during the procedure pain was referred, the block was considered failure and a conversion to general anaesthesia was performed.
After surgery, the patients were admitted to the post-anaesthetic recovery room, where they were continuously monitored using ECG as well as non-invasive blood pressure and pulse oximetry until the requirements for discharge were met. Postoperative analgesia was evaluated in the recovery room using a visual analogue pain scale (VAS) three hours after the block.
- Conditions
- Axillary Brachial Plexus Block
- Being tested
- Bupivacaine 0,5%
- Keywords
- Ultrasound, Axillary block, Bupivacaine, Minimum, Volume, Minimum volume of bupivacaine 0,5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0,5%Other
The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 0,5% | Other | Single arm study Receives: Other: Bupivacaine 0,5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the minimum effective volume of bupivacaine 0,5% with epinephrine For successful axillary brachial plexus block for hand surgery
Assessment of the success of ABPB A motor function score of 2 or less on the modified Bromage scale and also a lack of thermal sensitivity and response to a pinprick in the regions of the median, ulnar, radial and musculocutaneous nerves were considered characteristics of a successful block. Moreover, the surgery should be concluded without any complementary analgesia to confirm the success of the anaesthetic procedure.
Measured: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionNov 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary Brachial Plexus BlockStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Henrique Cunha Ferraro, Federal University of São Paulo
- Investigators
- Leonardo HC Ferraro, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421914
- Sponsor's protocol ID
- Unifesp-USG Axillary block
- Status last verified
- Nov 2012
- First submitted
- 21 Aug 2011
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Axillary Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT01421914
- Acronym / sponsor ID
- Unifesp-USG Axillary block
- Conditions
- Axillary Brachial Plexus Block
- Keywords
- Ultrasound, Axillary block, Bupivacaine, Minimum, Volume, Minimum volume of bupivacaine 0,5%
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Aug 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.
This is a study to calculate the minimum effective volume of bupivacaine 0,5% with epinephrine for successful axillary brachial plexus block for hand surgery in 50% of the patients (MEV50).
Detailed description
Study Design All patients had their demographic data recorded upon inclusion in the study. Routine preoperative monitoring was subsequently performed using ECG, non-invasive blood pressure measurements and pulse oximetry. Intravenous access was established and maintained with a crystalloid infusion.
The axillary approach using ultrasound (M-Turbo ® System with HFL 38x linear transducer 13-6 MHz, SonoSite, Bothell, WA, USA) and peripheral nerve stimulation (Stimuplex ® DIG RC, B. Braun, Melsung, Germany) guidance was performed to obtain brachial plexus block with the patient lying in the supine position. The needle used was a 22G x 50 mm (AEQ2250, BMD Group, Venezia, Italy). The puncture site was infiltrated with lidocaine 1% after asepsis and antisepsis skin treatment with chlorhexidine. After that, the ulnar, radial, median and musculocutaneous nerves were visualized by ultrasound (Figure 1) and had their identity confirmed by nerve stimulation. An initial dose of 5 mL of bupivacaine 0.5% with adrenaline (1:200,000) was injected in the proximity of each nerve. If severe pain at the injection was referred or, if nerve diameter changed during injection, injection was immediately interrupted, patient was removed form study and followed postoperatively for possible intraneural injection. The needle was repositioned during injection and perineural injected was ensured by ultrasound.
The efficacy of the block was assessed by an assessor blinded to injected volume. Assessments were conducted every 5 min up to a total of 30 min following the end of the injection of the local anaesthetic. Block assessment was finished either after surgical anaesthesia was achieved or,after 30 min had elapsed.
Success or failure of the block was used to dynamically reduce or increase, respectively, the volume of local anaesthetic that was used for the subsequent patient. When a block was achieved, the subsequent patient received a 0.5 mL reduction in the total volume of local anaesthetic per nerve. Upon failure of the block, the patient received a complementation of nerve blocks at a point distal to the axilla, and the volume of local anaesthetic delivered to the next patient was increased by 0.5 mL. After the block was assessed, the patients were cleared for surgery. During surgery, an infusion of 25-50 mcg.kg-1.min-1 of propofol was used to achieve proper sedation. Also, if during the procedure pain was referred, the block was considered failure and a conversion to general anaesthesia was performed.
After surgery, the patients were admitted to the post-anaesthetic recovery room, where they were continuously monitored using ECG as well as non-invasive blood pressure and pulse oximetry until the requirements for discharge were met. Postoperative analgesia was evaluated in the recovery room using a visual analogue pain scale (VAS) three hours after the block.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0,5% | Other | Other: Bupivacaine 0,5%Single arm study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1 and 2 adult patients scheduled for ambulatorial hand surgery were included
Key exclusion criteria (5 listed)
- cognitive impairment,
- coagulopathy,
- allergy to bupivacaine,
- 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 |
|---|---|---|
| Bupivacaine 0,5%The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min. | Other | Bupivacaine 0,5% |
Primary outcome
Determining the minimum effective volume of bupivacaine 0,5% with epinephrine For successful axillary brachial plexus block for hand surgery
Time frame: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes.
Assessment of the success of ABPB A motor function score of 2 or less on the modified Bromage scale and also a lack of thermal sensitivity and response to a pinprick in the regions of the median, ulnar, radial and musculocutaneous nerves were considered characteristics of a successful block. Moreover, the surgery should be concluded without any complementary analgesia to confirm the success of the anaesthetic 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 19 Nov 2012.
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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.
Leonardo HC Ferraro, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0,5% in people with Axillary Brachial Plexus Block, run by Federal University of São Paulo at 1 site in Brazil.
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 1 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 19 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 1 site in Brazil. 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?
Determining the minimum effective volume of bupivacaine 0,5% with epinephrine For successful axillary brachial plexus block for hand surgery (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?
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 19 Nov 2012.