Fractures of the Distal RadiusPhase 4NCT02129270
Hematoma Block for Reduction of Distal Radius Fractures
A Phase 4 study testing Lidocaine HCl 2% . and Lidocaine HCl 1% in people with Fractures of the Distal Radius, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the fracture site (Hematoma block) is more effective in terms of pain relieving then injection of 10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction of distal radius fractures. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Fractures of the Distal Radius
- What is being tested?
- Lidocaine HCl 2% . and Lidocaine HCl 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to Aug 2018
- Phase
- Phase 4
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Fractures of the distal radius, with or without ulna fracture
Who cannot join
- Children,
- pregnant women,
- patients with infection or suspected infection on the site for injection.
- Patients whose condition requires general anesthesia (patients with more fractures other than the distal radius and ulna, patients with many damage...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures
The purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the fracture site (Hematoma block) is more effective in terms of pain relieving then injection of 10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction of distal radius fractures.
- Conditions
- Fractures of the Distal Radius
- Being tested
- Lidocaine HCl 2% ., Lidocaine HCl 1%
- Keywords
- Fractures of the distal radius, Hematoma block, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HCl 2% .Drug
Also called ESRACAIN
comparison of different dosages of drug
Lidocaine HCl 1%Drug
Also called ESRACAIN
comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine HCl 2% | Active comparator | Lidocaine HCl 2% (200mg/10ml) 10 ml. Receives: Drug: Lidocaine HCl 2% . |
| Lidocaine HCl 1% | Experimental | Lidocaine HCl 1% (100mg/10ml) 15-20 ml. Receives: Drug: Lidocaine HCl 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will be measured effective in terms of pain relieving with Visual Analog Scale.
Measured: 1 year
Secondary outcomes (1)
This study will be measured safe in terms of complications to injection.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures of the Distal RadiusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nimrod Rozen, Prof., Principal investigator, HaEemek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129270
- Sponsor's protocol ID
- 158-13-EMC
- Status last verified
- Feb 2020
- First submitted
- 7 Apr 2014
- Last updated
- 17 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Hematoma Block for Reduction of Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT02129270
- Acronym / sponsor ID
- 158-13-EMC
- Conditions
- Fractures of the Distal Radius
- Keywords
- Fractures of the distal radius, Hematoma block, Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 May 2014 (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 purpose of this study is to Prove that injection of 15 to 20 mL of lidocaine 1% into the fracture site (Hematoma block) is more effective in terms of pain relieving then injection of 10 mL of lidocaine 2%, and equally safe in terms of complications, for closed reduction of distal radius fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine HCl 2% | Active comparator | Drug: Lidocaine HCl 2% .Lidocaine HCl 2% (200mg/10ml) 10 ml. |
| Lidocaine HCl 1% | Experimental | Drug: Lidocaine HCl 1%Lidocaine HCl 1% (100mg/10ml) 15-20 ml. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Fractures of the distal radius, with or without ulna fracture
Key exclusion criteria (4 listed)
- Children,
- pregnant women,
- patients with infection or suspected infection on the site for injection.
- Patients whose condition requires general anesthesia (patients with more fractures other than the distal radius and ulna, patients with many damage...)
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 |
|---|---|---|
| Lidocaine HCl 2% .Also: ESRACAINcomparison of different dosages of drug | Drug | Lidocaine HCl 2% |
| Lidocaine HCl 1%Also: ESRACAINcomparison of different dosages of drug | Drug | Lidocaine HCl 1% |
Primary outcome
This study will be measured effective in terms of pain relieving with Visual Analog Scale.
Time frame: 1 year
1 secondary outcome
This study will be measured safe in terms of complications to injection.
Time frame: 1 year
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 17 Feb 2020.
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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.
Nimrod Rozen, Prof. principal investigator
HaEemek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine HCl 2% . and Lidocaine HCl 1% in people with Fractures of the Distal Radius, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 4 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 17 Feb 2020. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
This study will be measured effective in terms of pain relieving with Visual Analog Scale. (time frame: 1 year). 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 Feb 2020.