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

NCT01964911 | Completed Phase 4 DMC

• 1 other identifier: RC13_0252
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Hypertensive Leg Ulcer

Keywords

Martorell ulcer; Hypertensive leg ulcer; Pain; Continuous nerve block; Ropivacaïne; Local anesthesic

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 days

Secondary Outcomes (5)

• Evolution of NRS

  6 month

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

  6 month

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

  6 month

• To assess pain consequences using Hospital Anxiety and Depression Scale (HAD) and Brief Pain Inventory questionnaire(BPI)

  6 month

• To assess microcirculatory evolution with a TCPO2 measure

  6 month

Study Arms (1)

Ropivacaïne

EXPERIMENTAL

Drug: Ropivacaïne

Interventions

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).

Ropivacaïne

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cécile DURANT, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: February 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: July 13, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

FR (1)