Humerus FractureNCT02756156
Low Dose Interscalene and Infraclavicular Block for Humerus Surgery
An observational study of Humerus Fracture, run by Kahramanmaras Sutcu Imam University.
Trial summary
Combining interscalene block with infraclavicular block for humerus surgery provides a unique surgical anaesthesia and postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humerus Fracture
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing humerus surgery.
Who may be able to join
- Patients accepting peripheral nerve block technique for humerus surgery
- Unilateral orthopedic humerus surgery
- 18 years of age or older
Who cannot join
- Patients refused peripheral nerve block
- Non-cooperate patients
- Neuropathy of any etiology in the affected extremity
Trial locations and contacts
No sites are listed yet.
About this study
Combining interscalene block with infraclavicular block for humerus surgery provides a unique surgical anaesthesia and postoperative analgesia.
Read the detailed description
Interscalene block provides effective surgical anaesthesia for shoulder and proximal arm surgery. However, sometimes it can be inadequate for distal arm surgery. Combining infraclavicular block with interscalene block may provide a successful surgical anaesthesia for humerus surgery.
- Conditions
- Humerus Fracture
- Keywords
- interscalene, infraclavicular, humerus surgery
- Medical subject headings
- Humeral Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of block
A complete sensory loss in distribution of the radial, median, ulnar, musculocutaneous and medial cutaneous nerves of the arm
Measured: 10 min.- 20 min.
Secondary outcomes (3)
Technique duration
Measured: 5 min.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 24 hours
Complication rate
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerus FractureStudies 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Bilal, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756156
- Sponsor's protocol ID
- 76263
- Status last verified
- Mar 2016
- First submitted
- 15 Mar 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Interscalene and Infraclavicular Block for Humerus Surgery
- ClinicalTrials.gov ID
- NCT02756156
- Acronym / sponsor ID
- 76263
- Conditions
- Humerus Fracture
- Keywords
- interscalene, infraclavicular, humerus surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 29 Apr 2016 (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.
Combining interscalene block with infraclavicular block for humerus surgery provides a unique surgical anaesthesia and postoperative analgesia.
Detailed description
Interscalene block provides effective surgical anaesthesia for shoulder and proximal arm surgery. However, sometimes it can be inadequate for distal arm surgery. Combining infraclavicular block with interscalene block may provide a successful surgical anaesthesia for humerus surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing humerus surgery.
Key inclusion criteria (3 listed)
- Patients accepting peripheral nerve block technique for humerus surgery
- Unilateral orthopedic humerus surgery
- 18 years of age or older
Key exclusion criteria (3 listed)
- Patients refused peripheral nerve block
- Non-cooperate patients
- Neuropathy of any etiology in the affected extremity
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 block
Time frame: 10 min.- 20 min.
A complete sensory loss in distribution of the radial, median, ulnar, musculocutaneous and medial cutaneous nerves of the arm
3 secondary outcomes
Technique duration
Time frame: 5 min.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 24 hours
Complication rate
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Humerus Fracture, run by Kahramanmaras Sutcu Imam University.
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 3 inclusion and 3 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 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bora Bilal, Asist. Prof. (+903442803245, bilalbora@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of block (time frame: 10 min.- 20 min.). 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 29 Apr 2016.