New pain shot could replace catheters after leg amputation
NCT ID NCT05140499
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two standard pain relief methods after below-knee amputation: a long-lasting numbing injection (liposomal bupivacaine) versus a continuous nerve catheter that delivers numbing medicine. The goal was to see which provides better pain control and reduces the need for opioids. Only 11 people took part before the study was stopped early, so the results are very preliminary.
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) and bupivacaine hydrochloride
- What this could lead to
- If this works, it could show that a single injection controls pain as well as a catheter, possibly reducing opioid use and simplifying recovery after amputation.
- What could go wrong
- This is a very small pilot study (11 participants) that was terminated early, so results are preliminary and may not apply widely. Neither method is new, so the upside is modest.
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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11 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Dec 2025
- Lead sponsor
-
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: * American Society of Anesthesiologists Physical Status Classification I-IV * Scheduled for primary amputation or stump revision * English speaking Exclusion Criteria: * Patients unable to cooperate or consent to the study * Allergy to local anesthetics * Existing infection at planned needle insertion site * BMI \> 40kg/m2 * Patients with a history of coagulopathy * Emergency amputations * Contralateral amputations * Patients with a substance use disorder diagnosis * Patients on opioids \>90 morphine milligram equivalents (MME)/day
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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.
Contacts and locations
Locations
-
Maine Medical Center
Portland, Maine, 04102, United States
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