Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 50 and up

Nerve blocks before surgery for older adults with lower leg fractures

Official title: Pre-Incision Peripheral Nerve Blocks Versus No Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults: A Pilot Feasibility Study

Run by University of Maryland, Baltimore · NCT07217626 · Data updated 2026-11-12

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

PhasePhase 4
Study typeInterventional
Ages50 Years and up
SexAll
Enrollment34 (estimated)
SponsorUniversity of Maryland, Baltimore
Academic / other
Locations1 site (Baltimore, Maryland)
StatusRecruiting
StartedFebruary 24, 2026
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedMarch 30, 2026
Trial IDNCT07217626 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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).

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Maryland
    Baltimore, Maryland, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.