What is the mechanism of action of this treatment?

The most common treatments for bunions include conservative methods, pharmacological treatments, and surgical interventions. Local anesthetics like ropivacaine, as studied in PRF-110, work by blocking nerve signals in the area where they are applied, providing significant pain relief post-surgery. This is crucial for bunion patients as it helps manage post-operative pain effectively, allowing for a smoother recovery and improved mobility. By reducing pain, these treatments can enhance the overall quality of life and facilitate faster rehabilitation.

What side effects are associated with this type of intervention?

The most common side effects of local anesthetics like ropivacaine, used in treatments such as PRF-110 for bunion surgery, include localized pain at the injection site, temporary numbness, and potential allergic reactions. In rare cases, systemic toxicity can occur, leading to symptoms such as dizziness, tinnitus, and in severe cases, cardiovascular or central nervous system complications. Other common treatments for bunions, such as multi-drug injections, may also cause side effects like nausea, vomiting, and potential interactions with other medications.

What prior FDA approvals exist?

The FDA has approved various treatments for bunions, primarily focusing on surgical interventions to correct the deformity. Local anesthetics like ropivacaine, similar to PRF-110, are commonly used for post-operative pain management in bunionectomy procedures. These anesthetics are administered directly into the surgical site to provide extended pain relief, typically lasting up to 72 hours. Other related local anesthetics include bupivacaine and lidocaine, which are also used for similar purposes in post-surgical pain management.

What other types of research exist?

Promising alternatives to PRF-110 for bunion patients include liposomal bupivacaine (Exparel), which provides extended pain relief up to 72 hours, and regional nerve blocks using long-acting anesthetics. Additionally, advancements in multimodal analgesia, combining local anesthetics with non-opioid medications, may offer effective pain management options.

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PRF-110 for Postoperative Pain in Bunions

Phase 3

Waitlist Available

Research Sponsored by PainReform LTD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Pivotal Trial

Summary

This trial tests PRF-110, an oily solution with ropivacaine, for pain relief in patients having bunion surgery. It works by slowly releasing the pain medicine over a few days, reducing the need for other painkillers.

Who is the study for?

Adults over 18 scheduled for bunion surgery who can consent and communicate with the study team. Women must use effective birth control or be non-fertile. Participants need a BMI ≤35, no drug/alcohol abuse, not on certain medications like opiates or NSAIDs recently, and have good organ function.

What is being tested?

The trial is testing PRF-110, an extended-release ropivacaine solution for pain relief after bunion surgery. It's compared to a placebo and another painkiller in a double-blind setup where neither doctors nor patients know who gets which treatment.

What are the potential side effects?

Ropivacaine may cause side effects such as low blood pressure, nausea, vomiting, dizziness, numbness around the mouth, tingling sensations or ringing in the ears. Severe reactions are rare but could include seizures or heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of patients pain levels as an indication for the analgesic efficacy of PRF-110

Secondary study objectives

Comparison of opiate use to ropivacaine HCL injection

Comparison of opiate use to saline placebo

Measurement of patients pain levels of PRF-110 as compared to ropivacaine hydrochloride

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: PRF-110Experimental Treatment1 Intervention

PRF-110 3.6% ropivacaine, to be applied into the surgical wound

Group II: RopivacaineActive Control1 Intervention

Ropivacaine Hydrochloride 0.5%, up to 10 mL, to be applied into the surgical site

Group III: Saline .9%Placebo Group1 Intervention

Saline .9%, to b be applied into the surgical wound

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ropivacaine

2017

Completed Phase 4

~1960

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bunions include conservative methods, pharmacological treatments, and surgical interventions. Local anesthetics like ropivacaine, as studied in PRF-110, work by blocking nerve signals in the area where they are applied, providing significant pain relief post-surgery. This is crucial for bunion patients as it helps manage post-operative pain effectively, allowing for a smoother recovery and improved mobility. By reducing pain, these treatments can enhance the overall quality of life and facilitate faster rehabilitation.

Metatarsal head resection in the deformed, symptomatic rheumatic foot. A comparison of two methods.The dose effect of continuous passive motion in postoperative rehabilitation of the first metatarsophalangeal joint.Perioperative pain management and chronic postsurgical pain after elective foot and ankle surgery: a scoping review.