Evaluation of Block Duration in Type 2 Diabetes Patients

Phase 4

Completed

• Conditions: Diabetes Type 2
• Interventions: Drug: ropivacaine

• Registration Number: NCT01704612
• Lead Sponsor: Pierre and Marie Curie University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-10-07
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-21
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	ropivacaine	no diabete reveived 20 mL ropivacaine
Diabete group	ropivacaine	Patient with type 2 diabete received 20 mL ropivacaine

Primary Outcome Measures

Name	Time	Method
the duration of sensory block in hours	Day 0	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

Secondary Outcome Measures

Name	Time	Method
the duration of motor sciatic block	Day 0	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

Trial Locations

Locations (1)

APHP Pitié-Sampetriere; 🇫🇷 Paris, France