Nerve blocks before surgery for older adults with lower leg fractures
Pre-Incision Peripheral Nerve Blocks Versus No Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults: A Pilot Feasibility Study
This will test whether giving a peripheral nerve-block injection before surgery helps people aged 50 and older with lower leg fractures recover with fewer complications and less opioid use.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07217626 on ClinicalTrials.gov |
What this trial studies
This interventional Phase 4 pilot will give pre-incision peripheral nerve blocks as part of anesthetic care for hospitalized patients aged 50 and older who have isolated, radiographically confirmed lower extremity fractures requiring surgical fixation. The approach aims to block afferent pain signals before they trigger systemic stress and inflammatory responses, which may reduce physiologic strain in older adults. Key outcomes include clinical endpoints beyond pain control such as complications, length of stay, opioid requirements, and other perioperative morbidity. The work is conducted at a single center (University of Maryland, Baltimore) and compares outcomes of patients receiving pre-incision blocks with usual perioperative care.
Who should consider this trial
Good fit: Ideal candidates are adults age 50 or older with an isolated, radiographically confirmed lower-extremity fracture requiring definitive operative fixation during the same hospitalization and who can provide informed consent (or have a legal representative).
Not a fit: Patients with contraindications to peripheral nerve blocks (e.g., infection at the insertion site, active peripheral nerve injury, ongoing regional blockade, polytrauma, or when the surgeon/anesthesiologist deems the block unsafe) or those treated outside the enrolling hospital are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, pre-incision peripheral nerve blocks could reduce complications, shorten hospital stays, and lower opioid needs for older adults having surgery for lower extremity fractures.
How similar studies have performed: Prior studies in older adults with hip fractures have shown improved outcomes with peripheral nerve blocks, but comparable evidence for other lower-extremity fractures is limited and this application remains relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- University of Maryland — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Arissa Torrie, MD, MHS — University of Maryland, Baltimore
- Study coordinator: Arissa Torrie, MD, MHS
- Email: ATorrie@som.umaryland.edu
- Phone: 410 328 2630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.