70 Participants Needed

Pain Control for Ankle Fracture

Recruiting at 2 trial locations
ES
RF
JG
JK
Overseen ByJillian Kazley, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Massachusetts, Worcester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to take the standard post-operative pain regimen, which includes gabapentin, oxycodone, acetaminophen, and ibuprofen.

Is the treatment generally safe for humans?

Liposomal bupivacaine, a long-acting form of bupivacaine, has been shown to be safe for pain management in surgeries like breast augmentation and third molar extraction. However, there have been severe adverse reactions, including fatalities, associated with bupivacaine and etidocaine, highlighting the importance of being aware of potential risks.12345

How is the drug used for pain control in ankle fractures different from other treatments?

The drug, liposomal bupivacaine, is unique because it provides long-lasting pain relief for up to 72 hours with just a single injection, unlike standard treatments that may require more frequent dosing.16789

What data supports the effectiveness of the drug liposomal bupivacaine for pain control in ankle fractures?

Liposomal bupivacaine, a slow-releasing form of bupivacaine, has been shown to be effective for managing postsurgical pain, providing relief for up to 72 hours with a single application. However, a comprehensive review of trials found that liposomal bupivacaine often does not outperform standard local anesthetics like unencapsulated bupivacaine or ropivacaine, especially when used in peripheral nerve blocks.19101112

Who Is on the Research Team?

ES

Eric Swart, MD

Principal Investigator

Lahey Hospital & Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of ankle fracture (bimalleolar) that requires surgery using medial and lateral incisions. It's not for those with certain other fractures, open injuries, chronic opioid use, or who can't consent. Pregnant women, non-English speakers without translator access, and people on certain medications are also excluded.

Inclusion Criteria

You have only one injury and no other health problems.
I have a specific type of ankle fracture that requires surgery with cuts on both sides of my ankle.
I have a three-part ankle fracture and won't have surgery on the back part.
See 1 more

Exclusion Criteria

You have an open wound or injury.
I have been treated with a device outside my body to stabilize bones.
I have a broken ankle and only one side will be surgically fixed.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a long-acting local anesthetic cocktail, regional anesthesia, or traditional care for pain control during operative fixation of ankle fractures

Immediate perioperative period
1 visit (in-person for surgery)

Postoperative Monitoring

Participants are monitored for pain control and narcotic use for 72 hours post-surgery

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Long-Acting Local Anesthesia
  • Regional Anesthesia
Trial Overview The study compares the pain control effectiveness of a long-acting local anesthetic 'cocktail' versus regional anesthesia in patients having surgery to fix their broken ankles. Participants will be randomly assigned to one of three groups in different medical centers.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Regional AnesthesiaExperimental Treatment1 Intervention
Group II: Long-Acting Local AnesthesiaExperimental Treatment1 Intervention
Group III: Traditional Pain Control CareActive Control1 Intervention

Long-Acting Local Anesthesia is already approved in European Union, United States for the following indications:

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Approved in European Union as Bupivacaine for:
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Approved in United States as Bupivacaine for:
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Liposomal Bupivacaine for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Ropivacaine for:
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Approved in United States as Ropivacaine for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Etidocaine for:
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Approved in United States as Etidocaine for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Lahey Clinic

Lead Sponsor

Trials
74
Recruited
245,000+

Published Research Related to This Trial

Liposomal bupivacaine offers effective and safe pain management after surgery, providing long-lasting local analgesia for up to 72 hours with a single injection.
This slow-releasing formulation enhances patient satisfaction by reducing the need for additional pain medications following procedures like total ankle arthroplasties.
Administration technique of liposomal bupivacaine for total ankle arthroplasty.Matsumoto, T., Parekh, SG.[2017]
In a study of 76 patients undergoing surgery for ankle fractures, the use of liposomal bupivacaine significantly reduced postoperative pain scores compared to a placebo, with effects lasting up to 2 weeks after surgery.
Patients receiving liposomal bupivacaine required less Percocet for pain management in the first 4 hours post-surgery, indicating its efficacy in improving pain control immediately after the procedure.
The Use of Liposomal Bupivacaine Administered With Standard Bupivacaine in Ankle Fractures Requiring Open Reduction Internal Fixation: A Single-Blinded Randomized Controlled Trial.Davidovitch, R., Goch, A., Driesman, A., et al.[2018]
In a study of 50 patients undergoing vaginal reconstructive surgery, liposomal bupivacaine (LB) did not show any significant advantage over plain bupivacaine in terms of postoperative pain control, narcotic use, or length of hospital stay.
Despite LB's higher cost, the results indicate that it is not more effective than plain bupivacaine for managing pain after surgery, suggesting a need for further research to find the best pain management strategies.
Liposomal versus plain bupivacaine for pain control following vaginal reconstruction.Jensen, S., Amasyali, AS., Keheila, M., et al.[2023]

Citations

Administration technique of liposomal bupivacaine for total ankle arthroplasty. [2017]
The Use of Liposomal Bupivacaine Administered With Standard Bupivacaine in Ankle Fractures Requiring Open Reduction Internal Fixation: A Single-Blinded Randomized Controlled Trial. [2018]
Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]
Liposomal bupivacaine in posterior spine surgery: A piece of the puzzle for postoperative pain. [2023]
Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]
Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]
Toxic systemic reactions of bupivacaine and etidocaine. [2019]
Comparison of Liposomal Bupivacaine and Conventional Local Anesthetic Agents in Regional Anesthesia: A Systematic Review. [2023]
Liposomal Bupivacaine Use in Third Molar Impaction Surgery: INNOVATE Study. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Bupivacaine Extended-Release Liposomal Injection Versus Bupivacaine HCl for Early Postoperative Pain Control Following Wrist Operations: A Prospective, Randomized Control Trial. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
A Prospective Randomized Study Comparing Bupivacaine Hydrochloride Versus Bupivacaine Liposome for Pain Management After Distal Radius Fracture Repair Surgery. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Postoperative pain relief using local anesthetic instillation. [2019]
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