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

NCT07217626 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Local anesthesia injections

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Arissa Torrie, MD, MHS · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-24
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217626 on ClinicalTrials.gov