Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults
This study is looking at how local anesthesia injections, specifically peripheral nerve blocks, might help older adults (age 50 and up) who are having surgery for a lower leg fracture. These injections are given before surgery to numb the area. Doctors already know nerve blocks help with pain, but this study wants to see if they can also reduce the body's stress response to surgery. This is important because older adults can have more complications after these types of injuries and surgeries. The study will enroll 34 participants and is currently checking if it's possible to enroll people and collect the right information. This study aims to understand if these nerve blocks can improve overall outcomes beyond just pain relief.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 34 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will collect data for 12 months to assess feasibility and refine data collection methods.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults
At a glance
Conditions
NCT07217626
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Maryland
Baltimore, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Arissa Torrie, MD, MHS · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Feasibility of Participant Enrollment12 months
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
- Feasibility of Treatment Allocation12 months
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
- Refine Data Collection Methods12 months
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
- Assess Protocol ComplianceDay 30 + 5 post-randomization
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)