Local Multimodal Analgesia vs Regional Anesthesia for Ankle Fracture

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

Disqualifiers: Head injury, Lower extremity fracture, Stroke, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to manage pain after surgery for certain ankle fractures. It compares local multimodal analgesia (a mix of pain relief drugs given directly at the surgery site) with regional anesthesia (a numbing shot in a larger area). The goal is to determine which method more effectively reduces post-surgery pain. Ideal participants have an isolated rotational ankle fracture requiring surgery and can communicate with the research team. As an Early Phase 1 trial, this research aims to understand how these pain management methods work in people, offering participants a chance to contribute to groundbreaking medical insights.

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 research team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining pain relievers like morphine and bupivacaine is generally safe for reducing pain during surgeries. Studies report few serious problems with these local anesthesia methods.

For regional anesthesia, which uses bupivacaine to numb a larger area, research indicates it is commonly used in surgeries for broken bones, such as ankles. It is considered safe, though some studies mention the possibility of rebound pain, where pain returns after the anesthesia wears off.

Both treatments are used in surgeries today and are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for ankle fractures, which often involves regional anesthesia, local multimodal analgesia (LMA) introduces a new approach by combining multiple agents like morphine, ketorolac, and bupivacaine. This blend targets pain through different mechanisms, potentially enhancing pain relief and reducing the need for additional medication. Researchers are excited about LMA because it could offer more comprehensive pain control with fewer side effects compared to single-agent regional anesthesia. Additionally, the inclusion of ketorolac and morphine in LMA could provide both anti-inflammatory and analgesic benefits, making it a promising alternative for managing ankle fracture pain.

What evidence suggests that this trial's treatments could be effective for reducing post-operative pain in ankle fractures?

This trial will compare the effectiveness of local multimodal analgesia with regional anesthesia for pain management after ankle fracture surgery. Research has shown that local multimodal pain relief effectively reduces pain following ankle surgery. Studies have found that this approach lessens pain in the hospital and decreases the need for strong painkillers post-surgery. Patients reported experiencing less pain and requiring fewer pain medications during recovery.

Conversely, regional anesthesia, which participants in this trial may receive, is a well-known method in bone surgeries and effectively relieves pain. It acts quickly and wears off faster, aiding in pain management. Overall, both treatments have shown promise in reducing pain after ankle fracture surgeries. ^{2 6 7 8 9}

Who Is on the Research Team?

Justin Haller, MD

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for individuals with isolated rotational ankle fractures who need surgery, can give informed consent, and communicate in English or Spanish. It's not for those with drug dependency history, stroke, major neurological issues, other leg fractures, allergies to injection ingredients used in the study, head injuries or open fractures.

Inclusion Criteria

I need surgery for a broken ankle caused by twisting it.

Ability to provide informed consent

I can talk or email the research team.

Exclusion Criteria

I have a head injury along with my current condition.

Prior drug dependency

Allergies to any of the ingredients in the local injection or peripheral nerve block

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either local multimodal analgesia or regional anesthesia for pain management post-surgery

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and narcotic usage at 1, 2, 4, 8, and 24 hours post-operatively

24 hours

Multiple assessments (in-person)

Extended Follow-up

Participants are monitored for pain levels and narcotic usage up to 8 weeks post-operatively

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Local Multimodal Analgesia
• Regional Anesthesia

Trial Overview The study compares two pain control methods after ankle fracture surgery: one group receives local multimodal analgesia injections at the injury site; another gets regional anesthesia that numbs a larger area of the body.

How Is the Trial Designed?

Group I: Local multimodal analgesia group Experimental Treatment 1 Intervention

Local multimodal analgesia composition will include 5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.

Group II: Regional anesthesia group Active Control 1 Intervention

Standard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05019638

Local Multimodal Injection Versus Regional Anesthesia in ... Numerous studies have investigated the effect of these injections and shown a decrease in perioperative pain and the use of perioperative narcotics. A team of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31596802/

Efficacy of Multimodal Analgesic Injections in Operatively ... The use of multimodal surgical-site injections in operatively treated rotational ankle fractures is associated with a reduction in immediate in-hospital pain ...

3. journals.lww.com journals.lww.com/jbjsjournal/Fulltext/2019/12180/Efficacy_of_Multimodal_Analgesic_Injections_in.5.aspx?generateEpub=Article%7Cjbjsjournal:2019:12180:00005%7C10.2106/jbjs.19.00293%7C

Efficacy of Multimodal Analgesic Injections in Operatively ... Efficacy of Multimodal Analgesic Injections in Operatively Treated Ankle Fractures: A Randomized Controlled Trial. Hancock Kyle John MD; Rice, Olivia M. MD ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1268773124000432

The efficacy and safety of ankle blocks for foot and ... Ankle block may increase the duration of analgesia when compared with no intervention/sham block, but the evidence was very uncertain.

5. researchgate.net researchgate.net/publication/336377466_Efficacy_of_Multimodal_Analgesic_Injections_in_Operatively_Treated_Ankle_Fractures_A_Randomized_Controlled_Trial

Efficacy of Multimodal Analgesic Injections in Operatively ... Conclusions: The use of multimodal surgical-site injections in operatively treated rotational ankle fractures is associated with a reduction in immediate in- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12028960/

Efficacy and Safety of Different Local Anesthesia ... Local anesthesia techniques are effective in reducing pain in podiatric procedures. The safety of these techniques is high, with few serious complications.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7889403/

Retrospective chart review of perioperative pain ... The objective of this investigation was to evaluate the effect of preoperative peripheral nerve blockade on pain outcomes after ankle fracture ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1268773124000432?dgcid=rss_sd_all

A systematic review with meta-analysis and trial sequential ... Ankle block may increase the duration of analgesia when compared with no intervention/sham block, but the evidence was very uncertain, and decrease the duration ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03696199

Randomized Controlled Trial for Ankle Fracture Pain Control This study is a multicenter, three armed, prospective randomized control trial studying the effect of a long-acting local anesthetic "cocktail" in patients ...