Status:
NOT_YET_RECRUITING
Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Lower Extremity Fracture
Surgical Fracture Repair
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 beca...
Detailed Description
The potential for peripheral nerve blocks to improve clinical outcomes beyond analgesia is based on their ability to interrupt the physiologic stress response to surgical trauma near its origin. Tissu...
Eligibility Criteria
Inclusion
- 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))
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT07217626
Start Date
October 1 2025
End Date
December 31 2026
Last Update
October 16 2025
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201