SurgeryNCT03314948
Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30
An observational study of Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 15 Sep 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing an elective hand or forearm surgery
Who may be able to join
- 18 to 80 years old, with American Society of Anesthesiologists physical status I to IV, undergoing elective hand or forearm surgery under a BPB will be enrolled for this study.
Who cannot join
- Patient's refusal, American Society of Anesthesiologist physical status greater than IV, pregnancy, neuromuscular disease, prior surgery on the intraclavicular fossa, nerve injury or neurological disorders, bleeding tendency or evidence of coagulopathy, history of allergy to local anesthetic drugs, skin infection at the site of needle insertion, or contraindication to regional anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty.
- Conditions
- Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of costoclavicular brachial plexus block
Determine the success rate of the block in patients with body mass index greater than 30. Assess the effectiveness of the block by performing required assessments
Measured: Within 45 minutes of completion of block placement
Secondary outcomes (1)
Identification of costoclavicular space
Describe how the costoclavicular space and its contents are easily identifiable in patients with a body mass index greater than 30. Identify the costoclavicular space by using ultrasound
Measured: during placement of the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start16 Oct 2017
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Why it stopped: Due to lack of resources and changes in current practice, the study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher B. Robards, Mayo Clinic
- Investigators
- Christopher Robards, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314948
- Sponsor's protocol ID
- 17-006489
- Status last verified
- Jan 2022
- First submitted
- 16 Oct 2017
- Last updated
- 25 Jan 2022
- 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30
- ClinicalTrials.gov ID
- NCT03314948
- Acronym / sponsor ID
- 17-006489
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to lack of resources and changes in current practice, the study was terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 19 Oct 2017 (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.
The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing an elective hand or forearm surgery
Key inclusion criteria (1 listed)
- 18 to 80 years old, with American Society of Anesthesiologists physical status I to IV, undergoing elective hand or forearm surgery under a BPB will be enrolled for this study.
Key exclusion criteria (1 listed)
- Patient's refusal, American Society of Anesthesiologist physical status greater than IV, pregnancy, neuromuscular disease, prior surgery on the intraclavicular fossa, nerve injury or neurological disorders, bleeding tendency or evidence of coagulopathy, history of allergy to local anesthetic drugs, skin infection at the site of needle insertion, or contraindication to 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.
Primary outcome
Success rate of costoclavicular brachial plexus block
Time frame: Within 45 minutes of completion of block placement
Determine the success rate of the block in patients with body mass index greater than 30. Assess the effectiveness of the block by performing required assessments
1 secondary outcome
Identification of costoclavicular space
Time frame: during placement of the block
Results and safety
The study was stopped early (reason given: Due to lack of resources and changes in current practice, the study was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Christopher Robards, MD principal investigator
Mayo Clinic
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 Surgery, run by Mayo Clinic 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 25 Jan 2022. 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 was stopped early (reason given: Due to lack of resources and changes in current practice, the study was terminated). Results are not available in the source record.
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?
Success rate of costoclavicular brachial plexus block (time frame: Within 45 minutes of completion of block placement). 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 25 Jan 2022.