NCT01785693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

January 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2016

Completed
Last Updated

May 28, 2019

Status Verified

April 1, 2019

Enrollment Period

3.8 years

First QC Date

January 17, 2013

Last Update Submit

May 23, 2019

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Nerve blockFemoropopliteal bypassPostoperative analgesiaPeripheral circulationLevobupivacaineClonidinePain

Outcome Measures

Primary Outcomes (1)

  • total morphine consumption

    between hour 0 and hour 0+24h

Secondary Outcomes (12)

  • total morphine consumption

    between Hour 0 and Hour 0+72h

  • pain score at rest

    30, 60, 90 and 120 minutes after extubation

  • pain score

    every 4 hours during the 24 first post-operative hours

  • pain score

    every 8 hours during the next post-opeartive 48 hours

  • total sufentanil consumption

    between induction and extubation

  • +7 more secondary outcomes

Study Arms (2)

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.

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.

Drug: levobupivacaine, clonidine

Interventions

levobupivacaine, clonidineDRUG
Levobupivacaine + clonidineNaC1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 32769505DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1Pain

Interventions

LevobupivacaineClonidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Philippe JOUVE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

February 7, 2013

Study Start

January 30, 2013

Primary Completion

November 27, 2016

Study Completion

November 27, 2016

Last Updated

May 28, 2019

Record last verified: 2019-04

Locations

FR(1)