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ANGIOCATH
Monocentric Prospective Study, in Order to Assess Analgesia Provided by Continuous Sciatic Nerve Block, in Patients With Hypertensive Leg Ulcer.
Sponsor study identifier
interventional
13
1 country
1
Study Start
February 2014
Actual (reported)Primary Completion
January 2018
Actual (reported)Study Completion
July 13, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 13, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2013
Actual (reported)October 17, 2013
Actual (reported)February 2014
Actual (reported)January 2018
Actual (reported)July 13, 2018
Actual (reported)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
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
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nantes University Hospital
Nantes, 44093, France
Cécile DURANT, Dr
Nantes University Hospital
13 participants (actual enrollment reported by the registry).
First Submitted
October 15, 2013
First Posted
October 17, 2013
Study Start
February 2014
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
January 2018
Actual (reported)Study Completion
July 13, 2018
Actual (reported)Last Updated
March 5, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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