Neuropathic Pain Clinical Trial
Official title:
Peripheral Analgesia in Painful Diabetic Neuropathy
Chronic obliterative arteriopathy of the inferior limbs is a frequent condition observed in
diabetics. The later stages induce pain at rest and trophic disorders (ulcer, gangrene) that
lead to chronic limb ischemia. Without possible surgical revascularization ,pain management
and tissue healing are used to avoid amputation.
Prevalence of diabetes is twice higher in Reunion Island than in metropolitan France. As a
consequence, the rate co-morbobidities, such as chronic obliterative arteriopathy of the
inferior limbs, is also increases.
This study compares the efficiency of two analgesic treatments in diabetics with forefoot
injuries.
Patients are allocated in two groups regarding :
- their eligibility to analgesic treatment using continuous peripheral nerve blocks
- the unability of usual pain management to reduce their pain (pain visual analogic scale
equal to or more than 4).
When patient 's response to pharmacological analgesic treatment is sufficient (pain visual
analogic scale equal to or less than 3), patient is allocated to the control group.
Patients of experimental group received a continous analgesic treatment for 6 weeks using
ropivacaine (2mg/ml, flow rate 7 ml/h).
Patients of control group received an analgesic treatment according the recommended pain
ladder of World Health Organization (WHO). Opioids for mild-to-moderate pain are used in
combination with a non-opioid analgesic, such as paracetamol, at the second step of the
ladder. If regular maximum doses of opioids for mild-to-moderate pain do not achieve adequate
analgesia, then they should be replaced with an opioid for moderate-to-severe pain, such as
morphine.
Efficiency of both treatment is assessed the improvement of oxygen level in the tissue below
the skin of the injured forefoot through the study.
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