Exparel for Postoperative Pain

Phase 4

Waitlist Available

Led By William Mihalko, MD, PhD

Research Sponsored by Campbell Clinic

Eligibility Criteria Checklist

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

Must have

Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia

American Society of Anesthesiologists physical status 1, 2, or 3

Must not have

Undergoing unicompartmental TKA or revision TKA

Planned concurrent surgical procedure (e.g., bilateral TKA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 hours after surgery, post-operative day 14, post-operative day 42

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

"This trial is looking at how helpful a new type of pain management injection is for patients getting knee replacement surgery."

Who is the study for?

This trial is for patients undergoing primary unilateral total knee arthroplasty to manage postoperative pain and osteoarthritis. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely receiving the intervention.

What is being tested?

The clinical utility of an Intra-articular Posteromedial Surgeon Administered (IPSA) Block using Exparel is being assessed. This involves a surgeon directly administering the medication into the joint during knee replacement surgery to control pain after the operation.

What are the potential side effects?

While specific side effects of Exparel in this context are not listed, common ones may include localized reactions at injection site, nausea, constipation, or headache. More serious side effects could occur but vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for knee replacement surgery under spinal anesthesia.

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I am in good to moderate health with or without severe systemic disease.

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I need a knee replacement due to arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having partial or revision knee replacement surgery.

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I am scheduled for a surgery soon, such as both knee replacements.

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I have been using opioids daily for the past month.

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I am not allergic to the study's medications or have manageable reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study enrollment, on admission to surgery, on post anesthesia care unit (pacu) admission, every 15 minutes from pacu admission to discharge home, 12 hours after surgery, post-operative day (pod) 1, pod 2, pod 3, pod 14, pod 42

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study enrollment, on admission to surgery, on post anesthesia care unit (pacu) admission, every 15 minutes from pacu admission to discharge home, 12 hours after surgery, post-operative day (pod) 1, pod 2, pod 3, pod 14, pod 42

This trial's timeline: 3 weeks for screening, Varies for treatment, and study enrollment, on admission to surgery, on post anesthesia care unit (pacu) admission, every 15 minutes from pacu admission to discharge home, 12 hours after surgery, post-operative day (pod) 1, pod 2, pod 3, pod 14, pod 42 for reporting.