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

Official title

Pre-Incision Peripheral Nerve Blocks Versus No Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults: A Pilot Feasibility Study

Overview

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.

Detailed description

The potential for peripheral nerve blocks to improve clinical outcomes beyond analgesia is based on their ability to interrupt the physiologic stress response to surgical trauma near its origin. Tissue injury triggers nociceptive signals that travel through peripheral nerves to initiate a cascade of neuroendocrine and inflammatory responses, including the release of catecholamines, activation of the hypothalamic-pituitary-adrenal axis, and systemic inflammation. While younger patients can tolerate this stress response, older adults with limited physiologic reserve may experience organ dysfunction when these compensatory mechanisms become overwhelmed. By blocking afferent neural transmission before it reaches the central nervous system, peripheral nerve blocks may attenuate this cascade, potentially reducing sympathetic surge, myocardial oxygen demand, and the release of inflammatory mediators. Additionally, effective peripheral nerve blocks can reduce opioid requirements, avoiding adverse effects including respiratory depression, delirium, and impaired mobilization that particularly affect older adults. These mechanistic advantages may be especially important in older adults with lower extremity fractures, who face both the initial trauma and the additional physiologic burden of surgical repair.

While peripheral nerve blocks are well-established components of multimodal analgesia, emerging evidence suggests their benefits may extend beyond short-term analgesic effects. Recent studies of older adults with hip fractures have found peripheral nerve blocks are associated with additional benefits including reduced mortality, fewer serious adverse events, and increased days alive out of hospital. However, evidence for fractures distal to the hip remains limited. Although current Orthopaedic Trauma Association guidelines recommend peripheral nerve blocks as part of multimodal pain management for hip fractures, time pressures, and uncertainty about benefits beyond short-term analgesia have resulted in variable adoption among anesthesiologists and orthopaedic surgeons. Evidence supporting broader use of peripheral nerve blocks for improving clinical outcomes in lower extremity fractures is still needed.

To address this knowledge gap, a large multicenter randomized controlled trial is needed. However, prior to initiating such a trial, a pilot feasibility study will be conducted comparing pre-incision peripheral nerve blocks to no peripheral nerve blocks. The primary objective is to assess feasibility in terms of patient recruitment, adherence to treatment allocation, data collection methods, protocol compliance, and participant follow-up. This pilot phase will allow for refinement of the primary outcome measure, optimization of data collection procedures, establishment of recruitment rates, and identification of potential barriers to implementation before committing resources to a large-scale definitive trial.

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 betw

Primary outcome measures

• 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]

Eligibility criteria

Inclusion criteria

• 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

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

Exclusion criteria

• 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.
• Anticipated problems with follow-up compliance

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• University of Maryland — Baltimore

Identifiers

NCT: NCT07217626 · HP-00115610

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗