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Week-Long nerve block after amputation may stop phantom pain and slash opioid use

NCT ID NCT03461120

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This study tests whether a continuous nerve block given for 7 days after a leg amputation can prevent phantom limb pain and improve physical and emotional function. About 200 adults scheduled for a lower-limb amputation will receive either a high-concentration numbing medicine or a low-concentration one for one day followed by saltwater. The goal is to see if the longer, denser block reduces pain and the need for opioids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bupivacaine or ropivacaine (local anesthetics)
What this could lead to
If it works, this could point toward a standard way to prevent chronic phantom limb pain and reduce reliance on opioids after amputation.
What could go wrong
This is a Phase 4 trial, so the drugs are already approved, but the specific 7-day block approach may not prove better than standard care. Results may not apply to all amputation types.

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

208 people

The number who actually took part.

Started

Mar 2018

Finished

Aug 2026

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: * scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone * continuous peripheral nerve blocks are planned for perioperative analgesia * willing to have their perineural infusion extended for a total of 7 days * willing to undergo ambulatory perineural infusion following hospital discharge Exclusion Criteria: * Known hepatic or renal insufficiency * allergy to any study medication * pregnancy * incarceration * inability to communicate with the investigators * comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural infusion (e.g., current infection at the catheter insertion site, immune-compromised status of any etiology) * weight \< 45 kg * inability to contact the investigators during the perineural infusion, and vice versa (e.g., lack of telephone access) * investigator opinion that the potential subject is not a good candidate for this particular study

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston VA

    Boston, Massachusetts, 02130, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Fairview Hospital

    Cleveland, Ohio, 44111, United States

  • Mass. General Hospital

    Boston, Massachusetts, 02114, United States

  • Naval Medical Center San Diego

    San Diego, California, 92134, United States

  • University California San Diego

    San Diego, California, 92103, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States