Peripheral Analgesia in Painful Diabetic Neuropathy (DIALOXY)

Centre Hospitalier Universitaire de la Réunion

Status: Withdrawn

Conditions: Neuropathic Pain; Diabetic Foot Infection; Diabetic Neuropathy Peripheral

Treatments: Procedure: Analgesic treatment; Procedure: Continuous peripheral nerve blocks

Study type: Interventional

Funder types: Other

Identifiers

NCT03354806

2016/CHU/05

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Contraindication to ropivacaine
• Conditions that could alter hyperbaric measurements (anemia < 8 g/dl, cardiac or respiratory insufficiency)
• patients with planned limb amputation

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Continuous peripheral nerve blocks

Experimental group

Description:

Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks

Treatment:

Procedure: Continuous peripheral nerve blocks

Analgesic treatment

Active Comparator group

Description:

Pharmacological pain management in accordance with WHO's pain relief ladder

Treatment:

Procedure: Analgesic treatment