Clavicular FracturesNCT03933228
Analgesia for Clavicular Fracture and Surgery
An observational study of Clavicular Fractures, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
Trial summary
Compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Clavicular Fractures
- What is being tested?
- Interscalene-Cervical Plexus Block and Supraclavicular-Cervical Plexus Block
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 150
Who may be able to join
- Surgery of the clavicular fractures under combined cervical plexus plus brachial plexus block
- Urgent or planned surgery
Who cannot join
- Refused to sign informed consent
- Pregnant women
- Allergic to the local anesthetic
Trial locations and contacts
1 site in 1 country.
China1 site
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei, 061001
About this study
Official title: Ultrasound-Guided Combined Interscalene-Cervical Plexus Versus Combined Supraclavicular-Cervical Plexus Block for Surgical Anesthesia in Clavicular Fractures: A Retrospective Observational Study
Compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.
Read the detailed description
The primary objective of this study was to compare the effectiveness of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.The hypothesis of this study was that the supraclavicular-cervical plexus block could provide better anesthesia with less anesthesia related complications.
- Conditions
- Clavicular Fractures
- Being tested
- Interscalene-Cervical Plexus Block, Supraclavicular-Cervical Plexus Block
- Keywords
- Combined Interscalene-Cervical Plexus Block, Combined Supraclavicular-Cervical Plexus Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene-Cervical Plexus BlockProcedure or surgery
Ultrasound-Guided Combined Interscalene-Cervical Plexus Block
Supraclavicular-Cervical Plexus BlockProcedure or surgery
Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block
| Study group | Role | What they receive |
|---|---|---|
| Interscalene-Cervical Plexus Block | Ultrasound-Guided Combined Interscalene-Cervical Plexus Block Receives: Procedure: Interscalene-Cervical Plexus Block | |
| Supraclavicular-Cervical Plexus Block | Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block Receives: Procedure: Supraclavicular-Cervical Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success rate
Sensory blockade was assessed using the pinprick test at the surgery site
Measured: At time 15 minutes after the block
Secondary outcomes (1)
Acute complications
Number of participants with phrenic nerve palsy
Measured: At the end of surgery immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 May 2019
- Primary completion1 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicular FracturesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruizhao Lv, M.D, Principal investigator, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933228
- Sponsor's protocol ID
- 2019CZTCWM4
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2019
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Combined Interscalene-Cervical Plexus Versus Combined Supraclavicular-Cervical Plexus Block for Surgical Anesthesia in Clavicular Fractures: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT03933228
- Acronym / sponsor ID
- 2019CZTCWM4
- Conditions
- Clavicular Fractures
- Keywords
- Combined Interscalene-Cervical Plexus Block, Combined Supraclavicular-Cervical Plexus Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cangzhou Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 1 May 2019 (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.
Compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.
Detailed description
The primary objective of this study was to compare the effectiveness of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.The hypothesis of this study was that the supraclavicular-cervical plexus block could provide better anesthesia with less anesthesia related complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene-Cervical Plexus Block | – | Procedure: Interscalene-Cervical Plexus BlockUltrasound-Guided Combined Interscalene-Cervical Plexus Block |
| Supraclavicular-Cervical Plexus Block | – | Procedure: Supraclavicular-Cervical Plexus BlockUltrasound-Guided Combined Supraclavicular-Cervical Plexus Block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 150
Key inclusion criteria (2 listed)
- Surgery of the clavicular fractures under combined cervical plexus plus brachial plexus block
- Urgent or planned surgery
Key exclusion criteria (3 listed)
- Refused to sign informed consent
- Pregnant women
- Allergic to the local anesthetic
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 |
|---|---|---|
| Interscalene-Cervical Plexus BlockUltrasound-Guided Combined Interscalene-Cervical Plexus Block | Procedure or surgery | Interscalene-Cervical Plexus Block |
| Supraclavicular-Cervical Plexus BlockUltrasound-Guided Combined Supraclavicular-Cervical Plexus Block | Procedure or surgery | Supraclavicular-Cervical Plexus Block |
Primary outcome
Block success rate
Time frame: At time 15 minutes after the block
Sensory blockade was assessed using the pinprick test at the surgery site
1 secondary outcome
Acute complications
Time frame: At the end of surgery immediately
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 9 Apr 2024.
Related trials for Clavicular Fractures
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Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery
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Enrolling by invitation
Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)
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KT Tape for Pediatric Clavicle Fractures
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Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes
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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.
Ruizhao Lv, M.D principal investigator
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
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 Clavicular Fractures, run by Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
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 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: finished, as of the sponsor's last update on 9 Apr 2024. 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 China. 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?
Block success rate (time frame: At time 15 minutes after the block). 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 9 Apr 2024.