Recruiting

Nerve Blocks

Sponsor:

University of Maryland, Baltimore

Code:

NCT07217626

Conditions

Lower Extremity Fracture

Surgical Fracture Repair

Orthopaedic Trauma

Orthogeriatric Fractures

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Local anesthesia injections

Study Details

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

Lower Extremity Fracture

Surgical Fracture Repair

Orthopaedic Trauma

Orthogeriatric Fractures

Study ID

NCT07217626

Start date

Feb 24, 2026

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥50 years
2. Isolated fractures
3. Radiographically confirmed lower extremity fracture requiring surgical fixation including:

1. Femoral shaft
2. Distal femur
3. Patella
4. Proximal tibia
5. Tibial shaft
6. Distal Tibia
7. Pilon fractures
8. Ankle (malleolar fractures)
9. Calcaneus
10. Talus
11. Hindfoot/midfoot
4. Acute fracture receiving definitive fixation during injury hospitalization

4\) Ability to provide informed consent (patient or legally authorized representative (LAR))

Exclusion Criteria:

1. Contraindication to peripheral nerve block

1. Infection at planned needle insertion site
2. Patient refusal
3. Surgeon or anesthesiologist refusal secondary to the patient's medical status
2. Active peripheral nerve blockade from initial injury analgesic management is defined as:

a. Risk of local anesthetic systemic toxicity
3. Neurologic or vascular injuries in the affected limb
4. Polytrauma with traumatic brain injury
5. Thoracic injury and/or abdominal injury requiring surgical intervention
6. Current enrollment in a conflicting clinical trial
7. Acute or Subacute residence prior to injury
8. Incarcerated at the time of enrollment
9. Prior enrollment in this trial
10. Unable to obtain informed consent due to language barrier
11. Unable to obtain informed consent because a legally authorized representative was unavailable.
12. Anticipated problems with follow-up compliance

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Feasibility of Participant Enrollment [ Time Frame: 12 months ]
  • Feasibility of Treatment Allocation [ Time Frame: 12 months ]
  • Refine Data Collection Methods [ Time Frame: 12 months ]
  • Assess Protocol Compliance [ Time Frame: Day 30 + 5 post-randomization ]

Central Contacts and Locations

Central contacts

Locations

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

Arissa Torrie, MD, MHS

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Mar 30, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-03-30.