Diabetes Type 2
Conditions
Keywords
local anesthetic, sciatic, diabetes, block, duration
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.
Interventions
DRUGropivacaine
patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve
Sponsors
Centre Hospitalier Universitaire de Nīmes
Pierre and Marie Curie University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time necessary for onset sensory and motor block time in minutes | Day 0 | peroperative period |
| Failure of the block: yes/no | Day 0 | perop |
| occurrence of neurological omplications, yes/no | 1 month | — |
Countries
France
Outcome results
None listed