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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)

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ClinicalTrials.gov Identifier: NCT01785693
Recruitment Status : Unknown
Verified February 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Collaborator:
ARAMU Association
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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.


Condition or disease Intervention/treatment Phase
- Patients to Benefit a Planned Femoropopliteal Bypass Through PAOD (Peripheral Arterial Occlusive Disease) Stage II or III. Drug: levobupivacaine, clonidine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : February 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. total morphine consumption [ Time Frame: between hour 0 and hour 0+24h ]

Secondary Outcome Measures :
  1. total morphine consumption [ Time Frame: between Hour 0 and Hour 0+72h ]
  2. pain score at rest [ Time Frame: 30, 60, 90 and 120 minutes after extubation ]
  3. pain score [ Time Frame: every 4 hours during the 24 first post-operative hours ]
  4. pain score [ Time Frame: every 8 hours during the next post-opeartive 48 hours ]
  5. total sufentanil consumption [ Time Frame: between induction and extubation ]
  6. rate of reoperation [ Time Frame: between day1 and day30 ]
  7. mortality rate [ Time Frame: at day 30 ]
  8. 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 ]
  9. Hemodynamic tolerance [ Time Frame: between day 1 and day 30 ]
  10. nausea [ Time Frame: between day 1 and day 30 ]
  11. vomiting [ Time Frame: between day 1 and day 30 ]
  12. Bleeding score [ Time Frame: between hour 0 and hour 0+24h ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Philippe JOUVE University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01785693     History of Changes
Other Study ID Numbers: CHU-129
2012-002123-15
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local