Lower Extremity FracturePhase 4NCT07217626
Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults
A Phase 4 study testing Local anesthesia injections in people with Lower Extremity Fracture and Surgical Fracture Repair, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lower Extremity Fracture, Surgical Fracture Repair, Orthopaedic Trauma
- What is being tested?
- Local anesthesia injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 years
- Isolated fractures
- Radiographically confirmed lower extremity fracture requiring surgical fixation including:
- Femoral shaft
- Distal femur
- Patella
Show all 16Show fewer
- 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))
Who cannot join
- 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:
- Risk of local anesthetic systemic toxicity
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Heather Phipps, MPS, 410-706-2492, HPhipps@som.umaryland.edu
Andrea Howe, MBA, 410 706 6823, ahowe@som.umaryland.edu
About this study
Official title: Pre-Incision Peripheral Nerve Blocks Versus No Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults: A Pilot Feasibility Study
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.
Read more
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.
Read the 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.
- Conditions
- Lower Extremity Fracture, Surgical Fracture Repair, Orthopaedic Trauma, Orthogeriatric Fractures
- Being tested
- Local anesthesia injections
- Keywords
- Regional Anesthesia, Clinical Outcomes, Orthopaedic trauma, Perioperative Outcomes, Pilot Study, Lower Extremity Fractures, Orthogeriatric Fractures, Peripheral Nerve Blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia injectionsDrug
Also called peripheral nerve block
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 30 + 5 post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start24 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity FractureStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Feasibility Study
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arissa Torrie, University of Maryland, Baltimore
- Investigators
- Arissa Torrie, MD, MHS, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217626
- Sponsor's protocol ID
- HP-00115610
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Incision Peripheral Nerve Blocks Versus No Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07217626
- Acronym / sponsor ID
- HP-00115610
- Conditions
- Lower Extremity Fracture, Surgical Fracture Repair, Orthopaedic Trauma, Orthogeriatric Fractures
- Keywords
- Regional Anesthesia, Clinical Outcomes, Orthopaedic trauma, Perioperative Outcomes, Pilot Study, Lower Extremity Fractures, Orthogeriatric Fractures, Peripheral Nerve Blocks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| Pre-incision Peripheral Nerve Blocks | Active comparator | Drug: Local anesthesia injectionsLong-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 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥50 years
- Isolated fractures
- Radiographically confirmed lower extremity fracture requiring surgical fixation including:
- Acute fracture receiving definitive fixation during injury hospitalization
- 4) Ability to provide informed consent (patient or legally authorized representative (LAR))
Key exclusion criteria (16 listed)
- Contraindication to peripheral nerve block
- Active peripheral nerve blockade from initial injury analgesic management is defined as:
- Neurologic or vascular injuries in the affected limb
- Polytrauma with traumatic brain injury
- Thoracic injury and/or abdominal injury requiring surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local anesthesia injectionsAlso: peripheral nerve blockThe 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. | Drug | Pre-incision Peripheral Nerve Blocks |
Primary outcome
Feasibility of Participant Enrollment
Time frame: 12 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 Allocation
Time frame: 12 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 Methods
Time frame: 12 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 Compliance
Time frame: Day 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes
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Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries
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PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arissa Torrie, MD, MHS principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Local anesthesia injections in people with Lower Extremity Fracture and Surgical Fracture Repair, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arissa Torrie, MD, MHS (410 328 2630, ATorrie@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Participant Enrollment (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.