Clinical Trial: To Assess Analgesia Provided by Continuous Sciatic Nerve Block in Patients With Hypertensive Leg Ulcer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Monocentric Prospective Study, in Order to Assess Analgesia Provided by Continuous Sciatic Nerve Block, in Patients With Hypertensive Leg Ulcer.

Brief Summary:

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.

Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: number of patient with a 50% decrease of one of the pain NRS [ Time Frame: 3 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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

Original Secondary Outcome:

• 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 SF36 [ Time Frame: 6 month ]
  Quality of life using a standardized questionnaire : SF36
• To assess pain consequences using HAD and 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

Information By: Nantes University Hospital

Dates:
Date Received: October 15, 2013
Date Started: February 2014
Date Completion: June 2018
Last Updated: May 3, 2016
Last Verified: May 2016