Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With… (NCT01785693) | Clinical Trial Compass
CompletedPhase 4
Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With General Anesthesia, in the Femoropopliteal Bypass: Study of Post-operative Analgesia and Peripheral Circulation Downstream
France47 participantsStarted 2013-01-30
Plain-language summary
The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before induction of general anaesthesia, on analgesia postoperatively assessed by morphine consumption.
Applied to the patient at the beginning of general anesthesia, this technique could allow one hand, to reduce the need for opiates, on the other hand - due to anesthetized limb vasodilation - to improve tissue perfusion downstream.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.