Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults
Recruiting now · Phase 4
Conditions studied: Lower Extremity Fracture, Surgical Fracture Repair, Orthopaedic Trauma, Orthogeriatric Fractures
In brief
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.
Key facts
- Study ID
- NCT07217626
- Run by
- University of Maryland, Baltimore
- People needed
- 34
- Starts
- 2026-02-24
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-30
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Ability to provide informed consent (patient or legally authorized representative (LAR))
You may not qualify if…
- 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
Where it is running
- University of Maryland — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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