Actively Recruiting
Pre-Incision Peripheral Nerve Blocks Versus No Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults: A Pilot Feasibility Study
Led by University of Maryland, Baltimore · Updated on 2026-03-30
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Lower leg fractures are particularly challenging for older adults because their bodies handle stress less effectively than younger individuals. This can lead to more complications, longer healing times, and a higher risk of death. Anesthesiologists use nerve blocks to manage pain during surgery and recovery, which may also provide benefits beyond pain relief. Previous studies in older adults with hip fractures suggest nerve blocks might reduce deaths and complications, but it is unclear if these benefits apply to other types of lower leg fractures. The study compares pre-incision peripheral nerve blocks with no nerve blocks in older adults undergoing surgery for lower extremity fractures. The nerve blocks involve injections of local anesthesia within two hours before surgery to numb the fracture and surgical area using ultrasound guidance. Participants in the control group will receive usual anesthesia care without nerve blocks. This pilot study aims to test the feasibility of recruiting patients, delivering assigned treatments, collecting data, and following the study procedures before a larger trial is conducted. Participants will be monitored for treatment adherence, data collection quality, and protocol compliance up to 30 days after randomization. The primary measures focus on enrollment feasibility, treatment allocation, refining data methods, and protocol adherence over 12 months. The study includes older adults with confirmed fractures in various lower leg bones who require surgical fixation. Participants or their representatives must provide informed consent, and follow-up compliance will be tracked during the study period.
CONDITIONS
Brief Title
Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Isolated lower extremity fractures confirmed by imaging
- Fractures requiring surgical fixation in femoral shaft, distal femur, patella, proximal tibia, tibial shaft, distal tibia, pilon, ankle (malleolar), calcaneus, talus, or hindfoot/midfoot
- Acute fracture receiving definitive fixation during injury hospitalization
- Ability to provide informed consent by patient or legally authorized representative
You will not qualify if you...
- Contraindication to peripheral nerve block, including infection at needle site, patient refusal, or medical refusal
- Active peripheral nerve blockade from initial injury management with risk of local anesthetic toxicity
- Neurologic or vascular injuries in the affected limb
- Polytrauma with traumatic brain injury
- Thoracic or abdominal injury requiring surgery
- Current enrollment in a conflicting clinical trial
- Acute or subacute residence prior to injury
- Incarcerated at enrollment
- Prior enrollment in this trial
- Unable to obtain informed consent due to language barrier or lack of legally authorized representative
- Anticipated problems with follow-up compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (day of surgery)
Participants receive pre-incision peripheral nerve blocks or no peripheral nerve block before surgery for lower extremity fractures. The nerve block is performed within 2 hours before the surgical incision using ultrasound guidance to provide pain relief during surgery.
1 visit (in-person)
Duration - 30 days post-randomization
Participants are monitored for protocol compliance and clinical outcomes after surgery, including assessments up to 30 days post-randomization.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
A
Arissa Torrie, MD, MHS
H
Heather Phipps, MPS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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