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New pain shot could replace catheters after leg amputation

NCT ID NCT05140499

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

11 people

The number who actually took part.

Started

Aug 2022

Finished

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Pain, Postoperative

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.