Forearm FracturePhase 4NCT00763880
Hematoma Block as an Adjunct to Procedural Sedation for Forearm Fracture Reduction
A Phase 4 study testing Lidocaine and Saline in people with Forearm Fracture, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Forearm Fracture
- What is being tested?
- Lidocaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Sep 2008
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- English or Spanish speaking
- Ages 3-17
- Closed distal forearm fracture requiring reduction under sedation in the Emergency Department
- Fracture involves the distal third of the forearm
Who cannot join
- Multiple trauma victims
- Associated nerve or vascular damage
- Associated elbow or humerus injury
- Sensitivity or allergy to lidocaine
- Contraindications to procedural sedation
- Previous attempts at reduction for the same injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Children's Hospital/Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?
The purpose of our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.
- Conditions
- Forearm Fracture
- Being tested
- Lidocaine, Saline
- Keywords
- Hematoma block, Lidocaine, Forearm fracture, Radius fracture, Ulna fracture, Ketamine, Midazolam, Procedural sedation
- Medical subject headings
- Radius Fractures, Ulna Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine, Lidocaine hydrochloride
2% Lidocaine (no epinephrine) in the dose of 2.5 mg/kg to a maximum of 10mL will be instilled once into the fracture site in the form of a hematoma block.
SalineDrug
Also called Sodium Chloride
Volume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Subjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block. Receives: Drug: Lidocaine |
| Normal Saline | Placebo comparator | Subjects randomly assigned to this arm will receive normal saline by injection into their fracture site Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sedation time
Measured: Evaluated upon completion of procedure
Secondary outcomes (5)
Non-union
Measured: 1 month
Need for re-manipulation
Measured: 1 week
Adverse effects of sedation
Measured: For the duration of the procedure
Adverse effects of hematoma block
Measured: 1 month
Pain control
Measured: For entire duration of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startNov 2005
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Recruitment was taking longer than originally anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forearm 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Constantine, Rhode Island Hospital
- Investigators
- Erika Constantine, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763880
- Sponsor's protocol ID
- CMTT # 4040-05
- Status last verified
- Nov 2013
- First submitted
- 26 Sep 2008
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematoma Blocks in Forearm Fractures: An Effective Adjunct to Procedural Sedation?
- ClinicalTrials.gov ID
- NCT00763880
- Acronym / sponsor ID
- CMTT # 4040-05
- Conditions
- Forearm Fracture
- Keywords
- Hematoma block, Lidocaine, Forearm fracture, Radius fracture, Ulna fracture, Ketamine, Midazolam, Procedural sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was taking longer than originally anticipated.
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 Oct 2008 (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 our study is to determine if the use of a hematoma block together with intravenous sedation and analgesia is an effective means of managing forearm fractures in the Emergency Department. To determine this, we have designed a randomized, double-blind, placebo controlled trial of hematoma block versus saline for the manipulation of forearm fractures under conscious sedation with ketamine and midazolam. Our hypotheses are two-fold: First, the use of a hematoma block together with conscious sedation will allow for improved pain control. Second, the use of a hematoma block together with conscious sedation will allow us to use less sedation, therefore promoting faster recovery from sedation and more efficient patient turnover in the Emergency Department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineSubjects randomly assigned to this arm will receive 2% lidocaine by injection into their fracture site in the form of a hematoma block. |
| Normal Saline | Placebo comparator | Drug: SalineSubjects randomly assigned to this arm will receive normal saline by injection into their fracture site |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- English or Spanish speaking
- Ages 3-17
- Closed distal forearm fracture requiring reduction under sedation in the Emergency Department
- Fracture involves the distal third of the forearm
Key exclusion criteria (6 listed)
- Multiple trauma victims
- Associated nerve or vascular damage
- Associated elbow or humerus injury
- Sensitivity or allergy to lidocaine
- Contraindications to procedural sedation
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 |
|---|---|---|
| LidocaineAlso: Xylocaine, Lidocaine hydrochloride2% Lidocaine (no epinephrine) in the dose of 2.5 mg/kg to a maximum of 10mL will be instilled once into the fracture site in the form of a hematoma block. | Drug | Lidocaine |
| SalineAlso: Sodium ChlorideVolume of normal saline equivalent to providing 2.5mg/kg of 2% lidocaine, to a maximum of 10mL. | Drug | Normal Saline |
Primary outcome
Total sedation time
Time frame: Evaluated upon completion of procedure
5 secondary outcomes
Non-union
Time frame: 1 month
Need for re-manipulation
Time frame: 1 week
Adverse effects of sedation
Time frame: For the duration of the procedure
Adverse effects of hematoma block
Time frame: 1 month
Pain control
Time frame: For entire duration of procedure
Results and safety
The study was stopped early (reason given: Recruitment was taking longer than originally anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
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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.
Erika Constantine, MD principal investigator
Rhode Island Hospital
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 and Saline in people with Forearm Fracture, run by Rhode Island Hospital 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 4 inclusion and 6 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 19 Nov 2013. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Recruitment was taking longer than originally anticipated.). 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?
Total sedation time (time frame: Evaluated upon completion of procedure). 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 19 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.