Shoulder SurgeryPhase 2NCT01667315
Minimum Effective Volume of 0.375% Bupivacaine in Interscalene Brachial Plexus Block
A Phase 2 study testing Bupivacaine 0,375% in people with Shoulder Surgery, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The use of ultrasound in regional anesthesia enables reduction in the local anesthetic volume. The present study aimed to determine the minimum effective volume of 0.375% bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- Bupivacaine 0,375%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Sep 2013
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 65 years
- Candidates for an elective surgical intervention on the shoulder with indication for anesthesia via brachial plexus block
- Physical condition of I or II according to the American Society of Anesthesiologists
- Body mass index up to 35 kg.m-2
Who cannot join
- Chronic obstructive pulmonary disease
- Cognitive impairment or active psychiatric condition
- Infection at the site of the puncture for the block
- Coagulopathy
- Bupivacaine allergy
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Paulo
São Paulo, São Paulo, 04024-002
Luiz Fernando Saldanha de Almeida, MD, luizfsa@gmail.com
Marcelo Vaz Perez, MD PhD, marcelovazperez@gmail.com
About this study
Official title: Minimum Effective Volume of 0.375% Bupivacaine in Ultrasound- and Nerve Stimulator-guided Interscalene Brachial Plexus Block for Shoulder Surgery
The use of ultrasound in regional anesthesia enables reduction in the local anesthetic volume. The present study aimed to determine the minimum effective volume of 0.375% bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery. Following approval by the Research Ethics Committee, patients with a physical condition of I or II according to the American Society of Anesthesiologists, between 21 and 65 years old and subjected to elective surgery of the shoulder and interscalene brachial plexus block will be recruited. The volume of the anesthetic will be determined using a step-up/step-down method and based on the outcome of the preceding block. Positive or negative block results in a 1mL reduction or increase in volume, respectively. The success of the block is defined as the presence of motor block in two muscle groups and the absence of thermal and pain sensations in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis, pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will undergo statistical analysis in order to determine minimum effective volume of 0.375% bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function, evaluate diaphragm paralysis and its influence in pulmonary function.
- Conditions
- Shoulder Surgery
- Being tested
- Bupivacaine 0,375%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0,375%Drug
Positive or negative block results in a 1-mL reduction or increase in volume, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | Bupivacaine 0,375% Receives: Drug: Bupivacaine 0,375% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum effective volume of 0,375% bupivacaine
Minimum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery
Measured: 30 minutes
Secondary outcomes (3)
Maximum 0,375% bupivacaine volume that maintains the diaphragmatic function
Maximum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery without diaphragmatic block
Measured: Before block, 10, 20 and 30 minutes, 4 and 6 hours after
Pulmonary function
Spirometric evaluation of forced vital capacity
Measured: Before block, 30 minutes, 4 and 6 hours after
Diaphragmatic Function
Diaphragmatic movement on ultrasound
Measured: Before block, 30 minutes, 4 and 6 hours after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Fernando Saldanha de Almeida, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667315
- Sponsor's protocol ID
- Bupivacaine 0,375%
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Volume of 0.375% Bupivacaine in Ultrasound- and Nerve Stimulator-guided Interscalene Brachial Plexus Block for Shoulder Surgery
- ClinicalTrials.gov ID
- NCT01667315
- Acronym / sponsor ID
- Bupivacaine 0,375%
- Conditions
- Shoulder Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 17 Aug 2012 (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 use of ultrasound in regional anesthesia enables reduction in the local anesthetic volume. The present study aimed to determine the minimum effective volume of 0.375% bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery. Following approval by the Research Ethics Committee, patients with a physical condition of I or II according to the American Society of Anesthesiologists, between 21 and 65 years old and subjected to elective surgery of the shoulder and interscalene brachial plexus block will be recruited. The volume of the anesthetic will be determined using a step-up/step-down method and based on the outcome of the preceding block. Positive or negative block results in a 1mL reduction or increase in volume, respectively. The success of the block is defined as the presence of motor block in two muscle groups and the absence of thermal and pain sensations in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis, pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will undergo statistical analysis in order to determine minimum effective volume of 0.375% bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function, evaluate diaphragm paralysis and its influence in pulmonary function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: Bupivacaine 0,375%Bupivacaine 0,375% |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 21 and 65 years
- Candidates for an elective surgical intervention on the shoulder with indication for anesthesia via brachial plexus block
- Physical condition of I or II according to the American Society of Anesthesiologists
- Body mass index up to 35 kg.m-2
Key exclusion criteria (5 listed)
- Chronic obstructive pulmonary disease
- Cognitive impairment or active psychiatric condition
- Infection at the site of the puncture for the block
- Coagulopathy
- Bupivacaine allergy
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 0,375%Positive or negative block results in a 1-mL reduction or increase in volume, respectively. | Drug | Bupivacaine |
Primary outcome
Minimum effective volume of 0,375% bupivacaine
Time frame: 30 minutes
Minimum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery
3 secondary outcomes
Maximum 0,375% bupivacaine volume that maintains the diaphragmatic function
Time frame: Before block, 10, 20 and 30 minutes, 4 and 6 hours after
Pulmonary function
Time frame: Before block, 30 minutes, 4 and 6 hours after
Diaphragmatic Function
Time frame: Before block, 30 minutes, 4 and 6 hours after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine 0,375% in people with Shoulder Surgery, 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 4 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: status not confirmed, as of the sponsor's last update on 17 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum effective volume of 0,375% bupivacaine (time frame: 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 17 Aug 2012.