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)

May 23, 2019 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total morphine consumption
Time Frame: between hour 0 and hour 0+24h
between hour 0 and hour 0+24h

Secondary Outcome Measures

Outcome Measure
Time Frame
total morphine consumption
Time Frame: between Hour 0 and Hour 0+72h
between Hour 0 and Hour 0+72h
pain score at rest
Time Frame: 30, 60, 90 and 120 minutes after extubation
30, 60, 90 and 120 minutes after extubation
pain score
Time Frame: every 4 hours during the 24 first post-operative hours
every 4 hours during the 24 first post-operative hours
pain score
Time Frame: every 8 hours during the next post-opeartive 48 hours
every 8 hours during the next post-opeartive 48 hours
total sufentanil consumption
Time Frame: between induction and extubation
between induction and extubation
rate of reoperation
Time Frame: between day1 and day30
between day1 and day30
mortality rate
Time Frame: at day 30
at day 30
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
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
Hemodynamic tolerance
Time Frame: between day 1 and day 30
between day 1 and day 30
nausea
Time Frame: between day 1 and day 30
between day 1 and day 30
vomiting
Time Frame: between day 1 and day 30
between day 1 and day 30
Bleeding score
Time Frame: between hour 0 and hour 0+24h
between hour 0 and hour 0+24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

ARAMU Association

Investigators

  • Principal Investigator: Philippe JOUVE, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2013

Primary Completion (Actual)

November 27, 2016

Study Completion (Actual)

November 27, 2016

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-129
  • 2012-002123-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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