Clinical trial NCT01704612: Evaluation of Block Duration in Type 2 Diabetes Patients
Official title: Comparison of Subgluteal Sciatic Nerve Block Duration in Type-2 Diabetic and Non Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Type 2
Keywords: local anesthetic
sciatic
diabetes
block
duration
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
First posted: 2012-10-11
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: the duration of sensory block in hours
timeFrame: Day 0
Secondary outcomes:
measure: the duration of motor sciatic block
timeFrame: Day 0
Other outcomes:
measure: Time necessary for onset sensory and motor block time in minutes
timeFrame: Day 0
measure: Failure of the block: yes/no
timeFrame: Day 0
measure: occurrence of neurological omplications, yes/no
timeFrame: 1 month
Locations:
city: Paris
country: France
facility: APHP Pitié-Sampetriere
Study officials:
affiliation: APHP Pitié Salpetriere
name: Philippe Cuvillon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuvillon P, Reubrecht V, Zoric L, Lemoine L, Belin M, Ducombs O, Birenbaum A, Riou B, Langeron O. Comparison of subgluteal sciatic nerve block duration in type 2 diabetic and non-diabetic patients. Br J Anaesth. 2013 May;110(5):823-30. doi: 10.1093/bja/aes496. Epub 2013 Jan 24.