To Assess Analgesia Provided by Continuous Sciatic Nerve Block in Patients With Hypertensive Leg Ulcer (ANGIOCATH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01964911
First received: October 15, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are responsible of many side effects. Martorell ulcer arises predominantly in women over 60 years of age, with history of vascular disease, and therefore with a higher risk of adverse event. Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer extension and ischemia.

This is why pain management is one of the main challenge in treatments of these ulcers.

Continuous nerve block of lower limbs are often used during per and postoperative orthopaedic surgery. Few adverse events and rare serious adverse events related to local anesthesic are reported (respectively <1% and <1/1000), and few adverse events related to catheter are reported (<1%). Its benefits have been proved on post-operative pain management and reeducation.

The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in patients with hypertensive leg ulcer, during hospitalization.

Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic nerve block with ropivacaïne 0,2%, during 7 days.

Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during wound care, maximal and mean. These datas will be collected over two 3-days period : the first 3 days of hospitalization, in which pain treatment will be prescribed depending on pain intensity of the patient ; and the first 3 days of ropivacaïne treatment.

The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when receiving ropivacaïne.

Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.


Condition Intervention Phase
Hypertensive Leg Ulcer
Drug: Ropivacaïne
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monocentric Prospective Study, in Order to Assess Analgesia Provided by Continuous Sciatic Nerve Block, in Patients With Hypertensive Leg Ulcer.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • number of patient with a 50% decrease of one of the pain NRS [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    The main evaluation criteria will be at least a 50% decrease of one of the pain NRS (at rest, during wound care, maximal or mean) with 3 days of ropivacaïne treatment, compared to 3 days of usual analgesic treatment.


Secondary Outcome Measures:
  • Evolution of NRS [ Time Frame: 6 month ]
    NRS during the 7 days of ropivacaïne, and during the 6 months follow up

  • To assess patients's satisfaction with Patient Global Impression of Change [ Time Frame: 6 month ]
  • To assess quality of life using Short Form 36 (SF36) [ Time Frame: 6 month ]
    Quality of life using a standardized questionnaire : SF36

  • To assess pain consequences using Hospital Anxiety and Depression Scale (HAD) and Brief Pain Inventory questionnaire(BPI) [ Time Frame: 6 month ]
    Pain consequences using standardized questionnaire : HAD, BPI

  • To assess microcirculatory evolution with a TCPO2 measure [ Time Frame: 6 month ]
    Microcirculatory evolution with a TCPO2 measure before and after ropivacaïne treatment


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaïne Drug: Ropivacaïne

The first 3 days, analgesic treatments will be provided, as usual, depending on pain intensity (EN <3/10 : non opioids, EN 3-5/10 : weak opioids, EN>5/10 : strong opioids).

If NRS is still over 5/10, continuous nerve block will be proposed. Patients will receive ropivacaïne, 5 à 10 mL/h during 7 days, with possibility of one bolus before wound care, through a stimulating catheter stimulong sono®.

In association, analgesic treatments will be provided, as usual, depending on pain intensity (as during the first 3 days).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years old
  • Hospitalized for hypertensive leg ulcer with severe pain :
  • For which pain intensity has been collected over the first 3 days before catheter insertion (D0)
  • With severe pain (mean or at wound care) in spite of acetaminophen treatment (NRS ≥ 5/10), and/or with adverse events related to weak or strong opioids.
  • patients' written informed consent obtained

Exclusion Criteria:

  • Patients with moderate pain after 3 days of usual pain management in hospitalization : mean NRS<5/10 the 24 hours before D0
  • pregnant women
  • other ulcer causes, local or systemic infection
  • not able to provide informed consent or to answer the pain evaluation
  • dialysis patients
  • unstable active diseases
  • Charcot foot
  • Known allergy to any local anesthetics
  • Ankle-brachial index <0,6
  • hemodynamically significant stenosis on arterial Doppler ultrasound
  • current clopidogrel or prazugrel treatment the 10 days preceding catheter insertion
  • current clopidogrel or prazugrel treatment the 10 days preceding catheter insertion, with contraindication to salicylic acid
  • current anticoagulant treatment, with contraindication to LMWHs or UFH
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964911

Contacts
Contact: Cécile DURANT, Dr 02 40 08 78 55

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Cécile DURANT, Dr    02 40 08 78 55      
Contact: Joséphine THOMAZEAU, Ms.         
Principal Investigator: Cécile DURANT, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Cécile DURANT, Dr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01964911     History of Changes
Other Study ID Numbers: RC13_0252
Study First Received: October 15, 2013
Last Updated: July 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Martorell ulcer
Hypertensive leg ulcer
Pain
Continuous nerve block
Ropivacaïne
Local anesthesic

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014