Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-11 @ 2:50 PM
Study NCT ID:
NCT01785693
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2013-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLOC-FEMPOP
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-002123-15 | None | None | View |