One-Shot pain relief could replace pump for ankle surgery recovery
NCT ID NCT06995352
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 4 times
Summary
This study compares a single injection of liposomal bupivacaine (a long-lasting painkiller) to a continuous nerve block (which uses a pump and catheter) for pain after ankle surgery. Researchers want to see if the single injection works just as well, while being easier and safer. About 140 adults undergoing ankle surgery will be randomly assigned to one of the two pain management methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- liposomal bupivacaine (Exparel)
- What this could lead to
- If it works, this could offer a simpler, safer, and cheaper way to control pain after ankle surgery, reducing the need for opioid painkillers.
- What could go wrong
- This is a Phase 4 non-inferiority study, so it's not testing a new drug but comparing two existing methods. The liposomal version may not provide pain relief that lasts as long as the continuous nerve block.
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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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2027
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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18 years and older
- 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: 1. Adult patients of at least 18 years of age 2. Undergoing a primary, unilateral, moderate-to-severely painful ankle surgery 3. Planned single-injection adductor canal nerve block and popliteal-sciatic catheter 4. Weight \> 50 kg (to minimize the risk of local anesthetic toxicity) Exclusion Criteria: 1. chronic opioid or tramadol use: daily oxycodone equivalents \> 20 mg for \> 4 weeks 2. neuro-muscular deficit of the surgical limb 3. moderate pain (NRS \> 3) in an anatomic location other than the surgical site 4. surgery outside the sciatic and saphenous nerve distributions 5. history of opioid misuse 6. inability to communicate with the investigators 7. inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access) 8. incarceration 9. pregnancy 10. allergy to amide local anesthetics or other study medication 11. active lower extremity infection or other contraindications to a peripheral nerve catheter
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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University of California San Diego
La Jolla, California, 92137, United States