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Can a targeted nerve block cut opioid use and boost blood flow after leg bypass?

NCT ID NCT01785693

Symptom relief Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether adding a double nerve block (femoral and sciatic) before general anesthesia can reduce pain and morphine use after femoropopliteal bypass surgery in people with peripheral arterial disease. The block, using levobupivacaine and clonidine, may also widen blood vessels in the leg, potentially improving blood flow. Participants are adults aged 18-80 scheduled for this surgery, and the study measures morphine consumption, pain scores, and other outcomes.

What this could mean

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

Active substance
levobupivacaine and clonidine (nerve block)
What this could lead to
If effective, this nerve block could reduce opioid use and improve blood flow after leg bypass surgery, potentially speeding recovery.
What could go wrong
The trial is small and early, and results may not apply to all patients. Nerve blocks carry risks like bleeding or nerve damage.

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

47 people

The number who actually took part.

Started

Jan 2013

Finished

Nov 2016

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 to 80 years

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: * Patients to benefit a planned femoropopliteal bypass through PAOD stage II or III. * Aged 18 to 80 years. * Having given their consent. * Affiliated with a social security scheme. Exclusion Criteria: * Patients with PAOD stage I or IV. * Chronic respiratory failure. * Severe coronary insufficiency. * Renal or hepatic impairment. * Patients with chronic pain or preoperative long-term opioid treatment. * Patients with cognitive impairment (judged by the investigator) that may interfere with: * informed consent, * the collection of endpoints, * the use of patient-controlled analgesia. * Severe abnormality of hemostasis (platelets \<80.000 / ml) and / or of coagulation (PT \<50%, factor V \<50%). * Patients with diabetes mellitus and / or diabetic neuropathy. * Pregnant or nursing women, women of childbearing age. * Refusal of the protocol. * Minor or major protected patients. * Contraindications to one of the following products: levobupivacaine, clonidine, morphine, paracetamol, nefopam. \- Patients with a contra-indication to the administration of sufentanil: hypersensitivity to any component, hypersensitivity to morphine, hypersensitivity to opiates.

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Conditions

The condition(s) this trial relates to.

Pain peripheral arterial disease peripheral arterial occlusive disease 1

As listed by the trial registrant

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

Peripheral arterial occlusive disease

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

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