New knee injection could ease Post-Surgery pain
NCT ID NCT06946368
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This pilot study tests a new pain-numbing injection called IPSA, given by the surgeon directly into the back and inner side of the knee during total knee replacement. 60 adults undergoing knee replacement will be randomly assigned to receive either the new IPSA block plus standard local anesthesia, a standard thigh block plus local anesthesia, or local anesthesia alone. The study will measure pain levels, extra pain medication use, and patient satisfaction for up to 90 days after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EXPAREL (bupivacaine liposome injectable suspension) and bupivacaine hydrochloride
- What this could lead to
- If this works, it could offer a more effective way to manage pain after knee replacement, potentially reducing the need for opioids and improving recovery.
- What could go wrong
- This is a small, early pilot study with only 60 participants, so results may not apply to everyone. The new block technique may not prove better than standard approaches.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation: 1\. Subjects ages 18 or older at screening 2. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia 3. Primary indication for TKA is degenerative osteoarthritis of the knee 4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 6) 5. Able to provide informed consent, adhere to the study schedule, and complete all study assessments 6. Body Mass Index (BMI) ≥18 and \<40 kg/m2 \- Exclusion Criteria: * Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study: 1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs) 2. Planned concurrent surgical procedure (e.g., bilateral TKA) 3. Undergoing unicompartmental TKA or revision TKA 4. Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments 5. Inadequate sensory function below the knee as assessed by the Investigator 6. History of contralateral TKA within 1 year 7. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted 8. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years 9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study 10. Previous participation in an EXPAREL study 11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance 12. Currently pregnant, nursing, or planning to become pregnant during the study 13. Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study. 14. Any use of marijuana \[including Tetrahydrocannabinol (THC) and Cannabidiol (CBD)\] within 30 days prior to randomization, or planned use during the course of the study 15. Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Lutheran Hospital
RECRUITINGCleveland, Ohio, 44113, United States
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