Evaluation of Block Duration in Type 2 Diabetes Patients

Diabetes Type 2 Clinical Trial

— Diabeteblock  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704612
• Other study ID #: 2011-PC001
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2012
• Last updated: December 21, 2012
• Start date: July 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• ropivacaine
patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve

Locations

Country	Name	City	State
France	APHP Pitié-Sampetriere	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Pierre and Marie Curie University	Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time necessary for onset sensory and motor block time in minutes	peroperative period	Day 0	No
Other	Failure of the block: yes/no	perop	Day 0	No
Other	occurrence of neurological omplications, yes/no		1 month	No
Primary	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	No
Secondary	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	No