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 (BLOC-FEMPOP)
This study is not yet open for participant recruitment.
Verified February 2013 by University Hospital, Clermont-Ferrand
Sponsor:
University Hospital, Clermont-Ferrand
Collaborator:
ARAMU Association Loi 1901 (Anesthésie, Réanimation, Analgésie, Médecine d’Urgence)
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01785693
First received: January 17, 2013
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
- Patients to Benefit a Planned Femoropopliteal Bypass Through PAOD (Peripheral Arterial Occlusive Disease) Stage II or III. |
Drug: levobupivacaine, clonidine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Clermont-Ferrand:
Primary Outcome Measures:
- total morphine consumption [ Time Frame: between hour 0 and hour 0+24h ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- total morphine consumption [ Time Frame: between Hour 0 and Hour 0+72h ] [ Designated as safety issue: Yes ]
- pain score at rest [ Time Frame: 30, 60, 90 and 120 minutes after extubation ] [ Designated as safety issue: Yes ]
- pain score [ Time Frame: every 4 hours during the 24 first post-operative hours ] [ Designated as safety issue: Yes ]
- pain score [ Time Frame: every 8 hours during the next post-opeartive 48 hours ] [ Designated as safety issue: Yes ]
- total sufentanil consumption [ Time Frame: between induction and extubation ] [ Designated as safety issue: Yes ]
- rate of reoperation [ Time Frame: between day1 and day30 ] [ Designated as safety issue: Yes ]
- mortality rate [ Time Frame: at day 30 ] [ Designated as safety issue: Yes ]
- sedation score [ Time Frame: at hour0+30mn, at hour 0+1h, at hour 0+2h, at H0+4h, at hour 0+8h, at H0+16h, at hour 0+24h ] [ Designated as safety issue: Yes ]
- Hemodynamic tolerance [ Time Frame: between day 1 and day 30 ] [ Designated as safety issue: Yes ]
- nausea [ Time Frame: between day 1 and day 30 ] [ Designated as safety issue: Yes ]
- vomiting [ Time Frame: between day 1 and day 30 ] [ Designated as safety issue: Yes ]
- Bleeding score [ Time Frame: between hour 0 and hour 0+24h ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 48 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
NaC1
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.
|
Drug: levobupivacaine, clonidine |
|
Levobupivacaine + clonidine
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.
|
Drug: levobupivacaine, clonidine |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785693
Contacts
| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
Locations
| France | |
| CHU Clermont-Ferrand | Not yet recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
ARAMU Association Loi 1901 (Anesthésie, Réanimation, Analgésie, Médecine d’Urgence)
Investigators
| Principal Investigator: | Philippe JOUVE | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01785693 History of Changes |
| Other Study ID Numbers: | CHU-129, 2012-002123-15 |
| Study First Received: | January 17, 2013 |
| Last Updated: | February 5, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Nerve block Femoropopliteal bypass Postoperative analgesia Peripheral circulation |
Levobupivacaine Clonidine Pain |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Peripheral Arterial Disease Vascular Diseases Cardiovascular Diseases Atherosclerosis Arteriosclerosis Peripheral Vascular Diseases Anesthetics Levobupivacaine Bupivacaine Clonidine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Antihypertensive Agents Cardiovascular Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Anesthetics, Local |
ClinicalTrials.gov processed this record on May 19, 2013