Evaluation of Block Duration in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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For diabetic patients, peripheral nerve block is an interesting alternative to general anesthesia because it provides effective analgesia and may decrease haemodynamic complication. The fear of nerve injury after regional anaesthesia in diabetic patients is a concern that has neither been confirmed nor refuted by current literature. As a matter of fact, diabetic patients with neuropathy may be considered at increased risk because of the possibility for double crush syndrome when a chronic axon lesion related to diabetes is associated with an unexpected distal nerve injury related to regional anaesthesia.

Official Title
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Comparison of Subgluteal Sciatic Nerve Block Duration in Type-2 Diabetic and Non Diabetic Patients

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Drug: ropivacaine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabete group<br>Patient with type 2 diabete received 20 mL ropivacaine | Drug: ropivacaine<br>* patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve<br>* Other names: naropin;|
| Sham Comparator: Control group<br>no diabete reveived 20 mL ropivacaine | Drug: ropivacaine<br>* patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve<br>* Other names: naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the duration of sensory block in hours | The beginning of this term is defined by the end of the sciatic block injection, and the end of this period is defined by the reappearance of sensitivity to pin-prick test | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the duration of motor sciatic block | The beginning of this term is defined by the end of the sciatic block injection, and the end of this period is defined by the reappearance of motor function | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anesthetic, sciatic, diabetes, block, duration