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New treatment option for Lower Extremity Fracture
Official title Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults
ClinicalTrials.gov ID: NCT07217626
What this study is testing
What is Local anesthesia injections?
Local anesthesia injections is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for lower extremity fracture.
Also referred to as peripheral nerve block.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Fractures of the lower leg are especially difficult for older adults. They are more likely to have serious complications, require longer healing times, and have a higher risk of death This occurs because their bodies cannot tolerate stress as well as younger individuals.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Age ≥50 years
- Isolated fractures
- Radiographically confirmed lower extremity fracture requiring surgical fixation including:
- Femoral shaft
- Distal femur
You likely can't join if
- Contraindication to peripheral nerve block
- Infection at planned needle insertion site
- Patient refusal
- Surgeon or anesthesiologist refusal secondary to the patient's medical status
- Active peripheral nerve blockade from initial injury analgesic management is defined as: a. Risk of local anesthetic systemic toxicity
- Neurologic or vascular injuries in the affected limb
See the full eligibility criteria
- Age ≥50 years
- Isolated fractures
- Radiographically confirmed lower extremity fracture requiring surgical fixation including:
- Femoral shaft
- Distal femur
- Patella
- Proximal tibia
- Tibial shaft
- Distal Tibia
- Pilon fractures
- Ankle (malleolar fractures)
- Calcaneus
- Talus
- Hindfoot/midfoot
- Acute fracture receiving definitive fixation during injury hospitalization 4) Ability to provide informed consent (patient or legally authorized representative (LAR))
- Contraindication to peripheral nerve block
- Infection at planned needle insertion site
- Patient refusal
- Surgeon or anesthesiologist refusal secondary to the patient's medical status
- Active peripheral nerve blockade from initial injury analgesic management is defined as: a. Risk of local anesthetic systemic toxicity
- Neurologic or vascular injuries in the affected limb
- Polytrauma with traumatic brain injury
- Thoracic injury and/or abdominal injury requiring surgical intervention
- Current enrollment in a conflicting clinical trial
- Acute or Subacute residence prior to injury
- Incarcerated at the time of enrollment
- Prior enrollment in this trial
- Unable to obtain informed consent due to language barrier
- Unable to obtain informed consent because a legally authorized representative was unavailable.
- Anticipated problems with follow-up compliance
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.