BupivacaineNCT03472911
Retroclavicular Approach to Infraclavicular Block
An observational study of Bupivacaine, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bupivacaine
- What is being tested?
- minimum effective volume
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2018to 15 Mar 2018
- Phase
- Observational
- 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
Study population: Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.
Who may be able to join
- patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
- American Society of Anesthesiologists class I, II or III
Who cannot join
- patients <18 years old
- >65 years old
- body mass index (BMI) <20 or >35 kg/m2
- inability to provide written informed consent
- refusal of regional anesthesia
- pregnancy
- contraindication for regional anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research hospital
Antalya, 07100
About this study
Official title: Minimum Effective Volume of Bupivacaine 0.5% for Ultrasound-guided Retroclavicular Approach to Infraclavicular Brachial Plexus Block
In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.
Read the detailed description
Two rules were used to stop the study. First stopping rule was a fixed-sample-size. The investigators used an up-and-down method to estimate the threshold for an all-or-none response for present study design. Therefore, for sample size calculation, the investigators applied the formula by Dixon and Massey, n=2(SD/SEM)2 (SD: standard deviation and SEM: standard error of mean). Second stopping rule included demonstration of minimum of five consecutive up-and-down sequences. On the basis of previous studies with similar binary outcomes, the investigators estimated that a priori a minimum of five negative-positive up-and down deflections was required to calculate MEV50.
- Conditions
- Bupivacaine
- Being tested
- minimum effective volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimum effective volumeOther
The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey.
What is being measured
The primary outcome is the main question the study is designed to answer.
The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50)
The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey
Measured: 30 minutes
Secondary outcomes (1)
estimate the minimum effective volume in 95% of patients (MEV95).
To calculate the MEV95, data were analyzed using probit transformation and logistic regression.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start8 Jan 2018
- Primary completion1 Mar 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BupivacaineStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ali Sait Kavakli, M.D., Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472911
- Sponsor's protocol ID
- AntalyaTRH 20
- Status last verified
- Jan 2018
- First submitted
- 15 Mar 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Volume of Bupivacaine 0.5% for Ultrasound-guided Retroclavicular Approach to Infraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT03472911
- Acronym / sponsor ID
- AntalyaTRH 20
- Conditions
- Bupivacaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- 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.
In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.
Detailed description
Two rules were used to stop the study. First stopping rule was a fixed-sample-size. The investigators used an up-and-down method to estimate the threshold for an all-or-none response for present study design. Therefore, for sample size calculation, the investigators applied the formula by Dixon and Massey, n=2(SD/SEM)2 (SD: standard deviation and SEM: standard error of mean). Second stopping rule included demonstration of minimum of five consecutive up-and-down sequences. On the basis of previous studies with similar binary outcomes, the investigators estimated that a priori a minimum of five negative-positive up-and down deflections was required to calculate MEV50.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.
Key inclusion criteria (2 listed)
- patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
- American Society of Anesthesiologists class I, II or III
Key exclusion criteria (7 listed)
- patients <18 years old
- >65 years old
- body mass index (BMI) <20 or >35 kg/m2
- inability to provide written informed consent
- refusal of regional anesthesia
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 |
|---|---|---|
| minimum effective volumeThe determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey. | Other | – |
Primary outcome
The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50)
Time frame: 30 minutes
The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey
1 secondary outcome
estimate the minimum effective volume in 95% of patients (MEV95).
Time frame: 30 minutes
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 3 May 2018.
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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.
Ali Sait Kavakli, M.D. study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bupivacaine, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 3 May 2018. 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 Turkey (Türkiye). 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?
The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) (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 3 May 2018.