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.
Age ≥50 years
Isolated fractures
Femoral shaft
Distal femur
Contraindication to peripheral nerve block
Infection at planned needle insertion site
Patient refusal
Surgeon or anesthesiologist refusal secondary to the patient's medical status
Parallel
Local anesthesia injections
DrugThe 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.
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
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
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
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)
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