Peripheral Arterial Occlusive DiseasePhase 4BLOC-FEMPOPNCT01785693
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
A Phase 4 study testing levobupivacaine, clonidine in people with Peripheral Arterial Occlusive Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- levobupivacaine, clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2013to 27 Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- levobupivacaine, clonidine
- Keywords
- Nerve block, Femoropopliteal bypass, Postoperative analgesia, Peripheral circulation, Levobupivacaine, Clonidine, Pain
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levobupivacaine, clonidineDrug
| Study group | Role | What they receive |
|---|---|---|
| NaC1 | Other | 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. Receives: Drug: levobupivacaine, clonidine |
| Levobupivacaine + clonidine | Other | 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. Receives: Drug: levobupivacaine, clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine consumption
Measured: between hour 0 and hour 0+24h
Secondary outcomes (12)
total morphine consumption
Measured: between Hour 0 and Hour 0+72h
pain score at rest
Measured: 30, 60, 90 and 120 minutes after extubation
pain score
Measured: every 4 hours during the 24 first post-operative hours
pain score
Measured: every 8 hours during the next post-opeartive 48 hours
total sufentanil consumption
Measured: between induction and extubation
rate of reoperation
Measured: between day1 and day30
mortality rate
Measured: at day 30
sedation score
Measured: 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
Measured: between day 1 and day 30
nausea
Measured: between day 1 and day 30
vomiting
Measured: between day 1 and day 30
Bleeding score
Measured: between hour 0 and hour 0+24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study start30 Jan 2013
- Primary completion27 Nov 2016
- Study completion27 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- ARAMU Association
- Responsible party
- Sponsor
- Investigators
- Philippe JOUVE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785693
- Sponsor's protocol ID
- CHU-129
- Other IDs
- 2012-002123-15
- Acronym
- BLOC-FEMPOP
- Status last verified
- Aug 2026
- First submitted
- 17 Jan 2013
- Last updated
- 5 Aug 2026
- Results posted
- No
Publications
Charvin M, Longeras F, Jouve P, Cherprenet AL, Futier E, Pereira B, Duale C. Effects of adding a combined femoral and sciatic nerve block with levobupivacaine and clonidine to general anaesthesia in femoropopliteal bypass surgery: A randomised, double-blind, controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):787-795. doi: 10.1097/EJA.0000000000001263.
PubMed 32769505
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01785693
- Acronym / sponsor ID
- BLOC-FEMPOP / CHU-129
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- Nerve block, Femoropopliteal bypass, Postoperative analgesia, Peripheral circulation, Levobupivacaine, Clonidine, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- ARAMU Association
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- 27 Nov 2016 (actual)
- Study completion
- 27 Nov 2016 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaC1 | Other | Drug: levobupivacaine, clonidineThe 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. |
| Levobupivacaine + clonidine | Other | Drug: levobupivacaine, clonidineThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levobupivacaine, clonidine | Drug | Levobupivacaine + clonidine, NaC1 |
Primary outcome
total morphine consumption
Time frame: between hour 0 and hour 0+24h
12 secondary outcomes
total morphine consumption
Time frame: between Hour 0 and Hour 0+72h
pain score at rest
Time frame: 30, 60, 90 and 120 minutes after extubation
pain score
Time frame: every 4 hours during the 24 first post-operative hours
pain score
Time frame: every 8 hours during the next post-opeartive 48 hours
total sufentanil consumption
Time frame: between induction and extubation
rate of reoperation
Time frame: between day1 and day30
mortality rate
Time frame: 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
Hemodynamic tolerance
Time frame: between day 1 and day 30
nausea
Time frame: between day 1 and day 30
vomiting
Time frame: between day 1 and day 30
Bleeding score
Time frame: between hour 0 and hour 0+24h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 32769505Charvin M, Longeras F, Jouve P, Cherprenet AL, Futier E, Pereira B, Duale C. Effects of adding a combined femoral and sciatic nerve block with levobupivacaine and clonidine to general anaesthesia in femoropopliteal bypass surgery: A randomised, double-blind, controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):787-795. doi: 10.1097/EJA.0000000000001263.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe JOUVE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levobupivacaine, clonidine in people with Peripheral Arterial Occlusive Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total morphine consumption (time frame: between hour 0 and hour 0+24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.