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

RecruitingPhase 4

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

Who can join

Ages 50 and older · All sexes

Full eligibility 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

About the study

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 not currently known if nerve blocks work this well for other broken bones in the leg, like in the thigh or shin. Additional research is need to know if nerve blocks can help patients with all types of leg fractures recover faster and experience fewer problems.

Before the investigators start a large clinical trial, a small pilot study needs to be completed to determine if a larger clinical trial is feasible. This pilot study will evaluate the ability to recruit enough patients, ensure patients can receive the assigned treatment, collect data effectively, follow the study protocol, and track participants over time. The results will indicate whether the investigators are prepared to proceed with a full-scale trial and help refine the approach.

What is being tested

Sponsor: University of Maryland, Baltimore · Participants: 34 · Started: Feb 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07217626

Locations in the U.S.

MarylandUniversity of Maryland, Baltimore

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.