Nerve Blocks for Lower Extremity Fractures

Overseen By Heather Phipps, MPS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Maryland, Baltimore

Disqualifiers: Nerve block contraindication, Neurologic injuries, Polytrauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Duration of surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether nerve blocks, injections that numb pain, can aid older adults in recovering from lower leg fractures. Nerve blocks have already improved outcomes for hip fractures, but their effectiveness for other leg bones, such as the thigh or shin, remains uncertain. The trial will compare patients receiving these nerve blocks (local anesthesia injections) before surgery to those who do not, assessing whether the blocks lead to fewer complications and faster recovery. Suitable candidates for this trial have a recent leg fracture requiring surgery and can provide informed consent. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for local anesthesia injections?

Research has shown that nerve blocks, which involve injecting medicine to numb a specific area, are generally safe for surgeries. Studies have found that these blocks effectively reduce the need for other pain medications after surgery, easing recovery for patients.

Most patients tolerate nerve blocks well. They help decrease the use of opioids, strong painkillers with potential side effects. Although rare, risks such as nerve injury or infection can occur.

In summary, despite minor risks, nerve blocks are usually safe and effectively manage pain during and after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using pre-incision peripheral nerve blocks for lower extremity fractures because this method could offer longer-lasting pain relief right from the start of surgery. Unlike standard anesthesia options, which might include general anesthesia or neuraxial blocks, these nerve blocks use long-acting local anesthesia that targets pain specifically in the fracture area. This approach not only aims to enhance pain control during and after surgery but may also reduce the need for opioids, which can have significant side effects.

What evidence suggests that nerve blocks are effective for lower extremity fractures?

Research has shown that nerve blocks help older adults with hip fractures. Studies have found that these blocks lead to fewer deaths, fewer serious problems, and shorter hospital stays, suggesting they might do more than just relieve pain. Nerve blocks stop pain signals, reducing the need for opioid painkillers. In this trial, participants will receive either pre-incision peripheral nerve blocks or no peripheral nerve block for lower extremity fractures. Although less information exists about their effects on other leg fractures, the positive results for hip fractures strongly support considering their use for other leg breaks. ^{6 7 8 9 10}

Who Is on the Research Team?

Arissa Torrie, MD, MHS

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for older adults who have suffered fractures in their lower legs, such as hip or other leg bone breaks. Participants must be able to receive local anesthesia injections. Specific inclusion and exclusion criteria are not listed, but typically these would involve age restrictions, the type of fracture, overall health status, and ability to follow the study protocol.

Inclusion Criteria

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

I have a single broken bone.

I have a confirmed fracture in my lower leg or foot that needs surgery.

Exclusion Criteria

I do not have an infection at the needle site, and neither I nor my doctor refuse a nerve block.

I am at risk of side effects from local anesthesia due to nerve pain treatment.

I have nerve or blood vessel damage in my limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive pre-incision peripheral nerve blocks or no nerve blocks during surgical fixation of lower extremity fractures

Duration of surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 30-day follow-up phone call

30 days

1 phone call

Data Collection and Analysis

Refinement of data collection methods and assessment of protocol compliance

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Local anesthesia injections

Trial Overview The pilot study is testing whether peripheral nerve blocks before surgery can help older adults recover better from lower extremity fractures. It aims to see if this approach leads to fewer complications and shorter hospital stays compared to standard care without nerve blocks.

How Is the Trial Designed?

Group I: Pre-incision Peripheral Nerve Blocks Active Control 1 Intervention

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.

Group II: No peripheral nerve block Active Control 1 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 Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217626

Pre-Incision Peripheral Nerve Blocks for Lower Extremity ... Studies looking at older adults with hip fractures who received nerve blocks showed better overall outcomes: fewer deaths, fewer serious ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11458727/

Advancing pain management for extremity trauma Studies have demonstrated that pre-hospital peripheral nerve blocks in elderly hip fracture patients have been shown to effectively reduce ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091223005676

Peripheral regional anaesthesia and outcomes: a narrative ... We were able to determine that the majority of peripheral regional blocks showed benefits for patients and that permanent complications were rare.

4. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(17)31289-8/fulltext

Peripheral regional anaesthesia and outcome The majority of peripheral regional anaesthetic techniques have been shown to produce benefits for patients and hospital efficiency.

5. mdpi.com mdpi.com/1648-9144/56/8/388

Combination Preemptive Peripheral Nerve Block in Limb ... The major finding of our study is that preoperative single-injection PNB as a part of multimodal regimen in extremity surgery attenuates postoperative pain ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10239283/

A Comprehensive Review on the Efficacy of Nerve Blocks in ... This article review analyzed the effectiveness of utilizing nerve blocks to reduce the need for postoperative anesthetic and analgesic medications.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772632022000204

Regional anesthesia for acute and subacute orthopedic ... This paper describes use of regional aesthesia for surgical intervention of extremity fractures in patients who present following traumatic injury.

8. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.14088

Peripheral nerve block in ankle fracture surgery: a qualitative ... Peripheral nerve blocks are considered safe; they reduce postoperative opioid consumption 2 and their long-lasting effect improves patient ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7214073/

PERIPHERAL NERVE BLOCKS FOR PERIOPERATIVE ... This review focuses on techniques and applications of lower extremity nerve blocks in patients having orthopedic surgery or trauma of the lower extremity.

10. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(17)33398-6/fulltext

Complications of peripheral nerve blocks Serious complications of peripheral nerve blocks include nerve injury, catheter infection, bleeding, and LAST.