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Completed

NCT Number: NCT01964911

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

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.

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Key information

Conditions

Hypertensive Leg Ulcer Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ropivacaïne

Drug

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 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).

Primary outcomes

  1. number of patient with a 50% decrease of one of the pain NRS

    Time frame: 3 days

    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 outcomes

  1. Evolution of NRS

    Time frame: 6 month

    NRS during the 7 days of ropivacaïne, and during the 6 months follow up

  2. To assess patients's satisfaction with Patient Global Impression of Change

    Time frame: 6 month

  3. To assess quality of life using Short Form 36 (SF36)

    Time frame: 6 month

    Quality of life using a standardized questionnaire : SF36

  4. 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

  5. To assess microcirculatory evolution with a TCPO2 measure

    Time frame: 6 month

    Microcirculatory evolution with a TCPO2 measure before and after ropivacaïne treatment

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: ANGIOCATH

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2013
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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