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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07217626
Phase
PHASE4
Status
Recruiting
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Conditions

  • Lower Extremity Fracture
  • Orthogeriatric Fractures
  • Orthopaedic Trauma
  • Surgical Fracture Repair

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Local anesthesia injections — DRUG
    The peripheral nerve block should be performed within 2 hours before incision, either in the pre-operative holding area when called to the operating room or after positioning but prior to skin antisepsis in the operating room. The goal is to achieve an established neural blockade before surgical incision without delaying the surgical start time. All blocks must be performed using ultrasound guidance. Consistent with clinical practice, anesthesiologists will determine the appropriate balance between motor and sensory blockade based on patient factors, surgical approach, and clinical judgment.

Study Details

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 Dates

Start date
Feb 24, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Pre-incision Peripheral Nerve Blocks
    Long-acting local anesthesia for pre-incision peripheral nerve blocks that cover the fracture and surgical pain during definitive surgical fixation of lower extremity fractures.
  • No Intervention: No peripheral nerve block
    No peripheral nerve block for definitive surgical fixation of lower extremity fractures. Participants can receive standard anesthesia options for their surgical intervention including neuraxial or general anesthesia, surgical site infiltration, and multimodal analgesia.

Primary Outcome Measure

Feasibility of Participant Enrollment [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MarylandBaltimoreMaryland21201
Heather Phipps, MPS
[email protected]
410-706-2492
Andrea Howe, MBA
[email protected]
410 706 6823
Arissa Torrie, MD, MHS (PRINCIPAL_INVESTIGATOR)
Robert O'Toole, MD (SUB_INVESTIGATOR)

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By research site
University of Maryland· Baltimore, MD

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