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

NCT07217626 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HP-00115610
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Regional Anesthesia; Clinical Outcomes; Orthopaedic trauma; Perioperative Outcomes; Pilot Study; Lower Extremity Fractures; Orthogeriatric Fractures; Peripheral Nerve Blocks

Outcome Measures

Primary Outcomes (4)

• Feasibility of Participant Enrollment

  Participant enrollment will be assessed by monitoring screening and enrollment metrics, including: * Initiation of screening and recruitment at the clinical site * Ability of the clinical site to screen consecutive patients 50 years of age and older with lower extremity fractures * Proportion of patients who are screened for eligibility to participate in the trial * Proportion of patients who meet the eligibility criteria * Review of reasons for exclusion * Proportion of patients who provide informed consent * Length of time required to enroll up to 50 patients

  12 months

• Feasibility of Treatment Allocation

  Feasibility of the treatment allocation will be assessed using the following metrics: * Proportion of adherence to pre-incision peripheral nerve block allocation * Proportion of adherence to no peripheral nerve block allocation * Proportion of stage 2 consent acceptance rate among participants randomized to peripheral nerve blocks

  12 months

• Refine Data Collection Methods

  To refine the data collection methods, the following metrics will be reviewed: * Proportion of participants with missing data * Proportion of missing data to identify data fields that are not feasible to collect * Proportion of data errors to identify ways to improve the flow of the case report forms (CRFs) and data collection

  12 months

• Assess Protocol Compliance

  The following metrics will be used to assess compliance with the protocol: * Proportion of randomization errors * Proportion of participants who complete the 30-day follow-up phone call * Proportion of participants who withdraw from the trial (withdrawal of consent) * Proportion of participants who cannot be located (loss to follow-up)

  Day 30 + 5 post-randomization

Study Arms (2)

Pre-incision Peripheral Nerve Blocks

ACTIVE COMPARATOR

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.

Drug: Local anesthesia injections

No peripheral nerve block

NO INTERVENTION

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.

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.

Also known as: peripheral nerve block

Pre-incision Peripheral Nerve Blocks

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Study Officials

• Arissa Torrie, MD, MHS

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arissa Torrie, MD, MHS

CONTACT

410 328 2630; ATorrie@som.umaryland.edu

Heather Phipps, MPS

CONTACT

410-706-2492; hphipps@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot Feasibility Study

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 16, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The results of this pilot feasibility study protocol will be published on an open-access peer-reviewed journal.
• Access Criteria: The results of this pilot feasibility study protocol will be published on an open-access peer-reviewed journal.

Locations

US (1)