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New study tests safer pain control for High-Risk amputation patients

NCT ID NCT07640516

Symptom relief Sponsor: Kasr El Aini Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study compares two drugs, dexmedetomidine and fentanyl, when added to a standard numbing medicine (bupivacaine) for nerve blocks in high-risk patients having an above-knee amputation. The goal is to see which provides better pain control during and after surgery, and whether it reduces the need for additional morphine. The trial plans to enroll 64 adults with serious heart or lung conditions.

What this could mean

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

Active substance
Dexmedetomidine and fentanyl (added to bupivacaine for nerve block)
What this could lead to
If it works, this could point toward a better way to manage pain during and after above-knee amputation in high-risk patients, possibly reducing the need for strong opioids like morphine.
What could go wrong
This is a small, early-stage trial with only 64 participants, so results may not apply to everyone. The study is not yet recruiting, and it focuses on pain control, not curing the underlying condition.

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

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

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

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: * \- Age ≥18 years * Both sexes * ASA III-IV * Documented cardiac disease (e.g., EF \< 40%, NYHA II or higher) * Documented pulmonary disease (e.g., COPD with FEV1 \< 60%) * Scheduled for above-knee amputations Exclusion Criteria: * Neurological or intellectual disability * Drug abuse * Allergy to study drugs * Pregnancy * Contraindications to regional anesthesia (e.g., coagulopathy, local infection) * Significant renal or hepatic impairment( plts \<75000 or INR \>1.5) * Current anticoagulant therapy * severe haemodynamically unstability at the time of block performance, defined as map \> 65 mmhg but achieved by high-dose vasopressors (e.g., norepinephrine ≥ 0.1 mcg/kg/min) after fluid ressuscitation .

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As listed by the trial registrant

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

Above knee amputation Analgesia assessment Fentanyl VS dexmedetomidine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • KasrELainiH

    RECRUITING

    Cairo, Egypt

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