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january 2019
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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 :
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous peripheral nerve blocks | Experimental | Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks |
|
| Analgesic treatment | Active Comparator | Pharmacological pain management in accordance with WHO's pain relief ladder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous peripheral nerve blocks | Procedure | 6 weeks-ropivacaine treatment delivered by continuous peripheral nerve blocks Transcutaneous oxygen measurement is assessed on day 2, week 3 and week 6 under atmospheric and hyperbaric conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Foot tissue oxygenation on day 2 | Measurement of transcutaneous oxygen tension (TcPO2) at room conditions | on day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Foot tissue oxygenation in hyperaemia-induced condition on day 2 | Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions | on day 2 |
| Foot tissue oxygenation on week 6 | Measurement of transcutaneous oxygen tension (TcPO2) at room conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valérie NAKAMURA, MD | Centre Hpospitalier Universitaire de La REUNION | Principal Investigator |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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Comparative, monocentric study including 2 parallel groups. Patient's allocation is based on recommended criteria for catheters for continuous peripheral nerve blocks uses such as anlagesic treatment (ropivacain) tolerance and acceptance or analgesic treatment refusal
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| Analgesic treatment | Procedure | 6 weeks-analgesic treatment according to WHO's pain relief ladder Transcutaneous oxygen measurement is assessed on day 2, week 3 and week 6 under atmospheric and hyperbaric conditions |
|
| on week 6 |
| Foot tissue oxygenation in hyperaemia-induced condition on day 2 | Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions | on week 6 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |