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Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults

RecruitingPhase 4Ages 50 Years - anyAllUniversity of Maryland, Baltimore
NCT07217626 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The injury itself places significant strain on the body, and surgery adds additional stress. Anesthesiologists use nerve blocks to help manage pain during and after these injuries. A nerve block is an injection that numbs the fracture and surgery area by blocking pain signals. These injections help patients need fewer opioid medications. However, new research shows these nerve blocks may provide benefits beyond pain management. Studies looking at older adults with hip fractures who received nerve blocks showed better overall outcomes: fewer deaths, fewer serious complications, and shorter hospital stays. However, it is

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥50 years 2. Isolated fractures 3. Radiographically confirmed lower extremity fracture requiring surgical fixation including: 1. Femoral shaft 2. Distal femur 3. Patella 4. Proximal tibia 5. Tibial shaft 6. Distal Tibia 7. Pilon fractures 8. Ankle (malleolar fractures) 9. Calcaneus 10. Talus 11. Hindfoot/midfoot 4. Acute fracture receiving definitive fixation during injury hospitalization 4\) Ability to provide informed consent (patient or legally authorized representative (LAR)) Exclusion Criteria: 1. Contraindication to peripheral nerve block 1. Infection at planned needle insertion site 2. Patient refusal 3. Surgeon or anesthesiologist refusal secondary to the patient's medical status 2. Active peripheral nerve blockade from initial injury analgesic management is defined as: a. Risk of local anesthetic systemic toxicity 3. Neurologic or vascular injuries in the affected limb 4. Polytrauma with traumatic brain injury 5. Thoracic injury and/or abdominal injury requiring surgical intervention 6. Current enrollment in a conflicting clinical trial 7. Acute or Subacute residence prior to injury 8. Incarcerated at the time of enrollment 9. Prior enrollment in this trial 10. Unable to obtain informed consent due to language barrier 11. Unable to obtain informed consent because a legally authorized representative was unavailable. 12. Anticipated problems with follow-up compliance
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What it tests

  • Local anesthesia injections
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Where

1 site
University of Maryland
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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