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:
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

January 17, 2013
February 5, 2013
February 2013
November 2013   (final data collection date for primary outcome measure)
total morphine consumption [ Time Frame: between hour 0 and hour 0+24h ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01785693 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Course of the study Visit 1 (J-15 J-1): Pre-inclusion During a follow-up visit usual pathology, the doctor will propose to the patient to participate in the protocol. Information Form will be given to the patient to be read at home to maintain a sufficient time for reflection.

Visit 2 (J-1): Pre-anesthetic, the eve of the intervention:

During the pre-anesthetic consultation routine, the doctor will check the informed consent and then note the following information on the case report form: age, height, weight, sex of the patient.

Visit 3 (J0): Surgery One hour before surgery the patient will receive premedication with Hydroxyzine (Atarax ®).

Then the anesthetic team install patient in monitoring room so that the test products are administered according to the double-blind randomization schedule prepared in advance. When the block is made, the patient is brought into the operating room for general anesthesia and surgery.

By the end of surgery, the following data will be collected in the case report form :

  • Vital parameters (heart rate, blood pressure, PetCO2, SpO2) every 10 minutes and incidents.
  • Time of injection tested products and time of induction of general anesthesia.
  • Major Surgical times : incision, venous sampling when indicated, heparin bolus, clamping the superficial femoral artery, arterial unclamping, skin closure.
  • Duration of operation (in minutes from the incision to skin closure).
  • Intraoperative sufentanil consumption (micrograms).

Monitoring and medical care in Post Anaesthesia Carry Unit (PACU):

After surgery, the patient will be conducted in PACU. He will benefit from routine monitoring of vital parameters (heart rate, blood pressure, respiratory rate and SpO2).

Then patient extubation, according to usual criteria, will be performed: extubation of the patient is the H0, when all the time measurement start.

- H0: Extubation Morphine consumption will be measured continuously during the 72 first postoperative hours.

rSO2 be measured by NIRS during the first 12 first postoperative hours.

  • H0 +30 min: rating of pain (simple numerical scale) + sedation score
  • H0 +60 min: rating of pain + sedation score
  • H0 +90 min: rating of pain
  • H0 +120 min: rating of pain + sedation score
  • H0+4h: rating of pain + sedation score
  • H0+8h: rating of pain + sedation score
  • H0+12h: rating of pain
  • H0+16h: rating of pain + sedation score
  • H0+20h: rating of pain
  • H0+24h: rating of pain + sedation score + morphine consumption with PCA and number of requests over the last 24 hours.
  • H0+32h: rating of pain
  • H0+40h: rating of pain
  • H0+48h: rating of pain + morphine consumption with PCA and number of requests over the last 24 hours.
  • H0+56h: rating of pain
  • H0+64h: rating of pain
  • H0+72h: rating of pain + morphine consumption with PCA and number of requests over the last 24 hours.
  • At the end of PACU: rating of pain + sedation score

Thereafter, recovery time of ambulation will be registered and duration of hospital stay, rate of reoperation within 30 post-operative days and 30-day survival.

Adverse events will be collected to have information about hemodynamic tolerance of the products.

The patient is then monitored in the usual care of the disease.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
- Patients to Benefit a Planned Femoropopliteal Bypass Through PAOD (Peripheral Arterial Occlusive Disease) Stage II or III.
Drug: levobupivacaine, clonidine
  • 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.
    Intervention: 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.
    Intervention: Drug: levobupivacaine, clonidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
48
December 2013
November 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 80 Years
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01785693
CHU-129, 2012-002123-15
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
ARAMU Association Loi 1901 (Anesthésie, Réanimation, Analgésie, Médecine d’Urgence)
Principal Investigator: Philippe JOUVE University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP