Tibial Plateau FracturesPhase 4NCT06474949
Local Anesthetic for Plateau Fractures
A Phase 4 study testing Bupivacaine injection and Saline in people with Tibial Plateau Fractures, run by University of Washington.
Trial summary
Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Plateau Fractures
- What is being tested?
- Bupivacaine injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age >=18 year ,
- tibial plateau fracture undergoing Open Reduction and fixation"
Who cannot join
- allergy to bupivacaine
- Prolonged external fixator use
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay
Read the detailed description
Subjects will be randomized to bupivicaine or saline injection in the joint at the end of Open Reduction Internal Fixation of the tibial plateau fracture
- Conditions
- Tibial Plateau Fractures
- Being tested
- Bupivacaine injection, Saline
- Keywords
- tibial plateau fracture
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine injectionDrug
Injection at end of Open Reduction Internal Fixation
SalineOther
Also called Placebo
Injection at end of Open Reduction Internal Fixation
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Bupivacaine Receives: Drug: Bupivacaine injection |
| Saline | Placebo comparator | Saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain)
Pain at time of visit
Measured: From date of hospitalization to end of follow-up at 6 months
Secondary outcomes (1)
Length of stay for hospitalization
Length of stay for hospitalization
Measured: From date of hospitalization up to one month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FracturesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonah Hebert-Davies, University of Washington
- Investigators
- Jonah Hebert-Davies, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474949
- Sponsor's protocol ID
- STUDY00017105
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2024
- Last updated
- 26 Jun 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthetic for Plateau Fractures
- ClinicalTrials.gov ID
- NCT06474949
- Acronym / sponsor ID
- STUDY00017105
- Conditions
- Tibial Plateau Fractures
- Keywords
- tibial plateau fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 Jun 2024 (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.
Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay
Detailed description
Subjects will be randomized to bupivicaine or saline injection in the joint at the end of Open Reduction Internal Fixation of the tibial plateau fracture
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: Bupivacaine injectionBupivacaine |
| Saline | Placebo comparator | Other: SalineSaline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >=18 year ,
- tibial plateau fracture undergoing Open Reduction and fixation"
Key exclusion criteria (2 listed)
- allergy to bupivacaine
- Prolonged external fixator use
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 |
|---|---|---|
| Bupivacaine injectionInjection at end of Open Reduction Internal Fixation | Drug | Bupivacaine |
| SalineAlso: PlaceboInjection at end of Open Reduction Internal Fixation | Other | Saline |
Primary outcome
Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain)
Time frame: From date of hospitalization to end of follow-up at 6 months
Pain at time of visit
1 secondary outcome
Length of stay for hospitalization
Time frame: From date of hospitalization up to one month post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
Jonah Hebert-Davies principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine injection and Saline in people with Tibial Plateau Fractures, run by University of Washington.
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 2 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: opening soon, as of the sponsor's last update on 26 Jun 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Agel (206.744.4113, bagel@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain) (time frame: From date of hospitalization to end of follow-up at 6 months). 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 26 Jun 2024.