Peripheral Analgesia in Painful Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Foot tissue oxygenation on day 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patient
- •Diabetics with chronic obliterative arteriopathy of the inferior limbs
- •Permanent limb ischaemia with a TcPO2 of the front-foot of at least 10 mmHg under atmospheric conditions
- •Lack of surgical revascularization
- •No contraindication to hyperbaric therapy
- •Signed informed consent
排除标准
- •Contraindication to ropivacaine
- •Conditions that could alter hyperbaric measurements (anemia < 8 g/dl, cardiac or respiratory insufficiency)
- •patients with planned limb amputation
研究组 & 干预措施
Continuous peripheral nerve blocks
Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks
干预措施: Continuous peripheral nerve blocks (Procedure)
Analgesic treatment
Pharmacological pain management in accordance with WHO's pain relief ladder
干预措施: Analgesic treatment (Procedure)
结局指标
主要结局
Foot tissue oxygenation on day 2
时间窗: on day 2
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
次要结局
- Foot tissue oxygenation in hyperaemia-induced condition on day 2(on week 6)
- Foot tissue oxygenation on week 6(on week 6)