Evaluation of Block Duration in Type 2 Diabetes Patients

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabete animal studies demonstrated a longer period recovery after local anesthetic injection (perineural administration). No clinical study demonstrated a prolonged nerve block duration in diabete type 2 patients after peripheral nerve block. The investigators hypothesized that block recovery is delayed in diabetic patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pierre and Marie Curie University
• Collaborator: Centre Hospitalier Universitaire de Nīmes
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• age (50 80 yrs) with monofilament test 10 g (> 4/8)

Exclusion Criteria:

• refusal of sciatic nerve block,

• age < 50 yr or > 80 yr,

• American Society of Anesthesiologists state > IV,

• presence of contraindications to local anaesthesia (known allergy to local anaesthetics, sepsis),

• emergency surgery,

• patients unlikely to be fully cooperative during the study,

• psychiatric disorders, or

• those abusing alcohol or drugs, and

• participation in another study within the previous 30 days. Moreover, patients with preoperative estimated values of creatinine clearance < 50 mL min-1 (Cockroft and Gault Formula) or with glycosylated hemoglobin (A1c) level > 8 % or with type 1 diabetes mellitus (insulin therapy)