Back to resultsEvaluation of Block Duration in Type 2 Diabetes Patients (Diabeteblock)
Primary Purpose
Diabetes Type 2
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Type 2 focused on measuring local anesthetic, sciatic, diabetes, block, duration
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)
Sites / Locations
- APHP Pitié-Sampetriere
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Diabete group
Control group
Arm Description
Patient with type 2 diabete received 20 mL ropivacaine
no diabete reveived 20 mL ropivacaine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01704612
First Posted
October 7, 2012
Last Updated
December 21, 2012
Sponsor
Pierre and Marie Curie University
Collaborators
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01704612
Brief Title
Evaluation of Block Duration in Type 2 Diabetes Patients
Acronym
Diabeteblock
Official Title
Comparison of Subgluteal Sciatic Nerve Block Duration in Type-2 Diabetic and Non Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pierre and Marie Curie University
Collaborators
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
Keywords
local anesthetic, sciatic, diabetes, block, duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabete group
Arm Type
Active Comparator
Arm Description
Patient with type 2 diabete received 20 mL ropivacaine
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
no diabete reveived 20 mL ropivacaine
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Other Intervention Name(s)
naropin
Intervention Description
patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve
Primary Outcome Measure Information:
Title
the duration of sensory block in hours
Description
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
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
the duration of motor sciatic block
Description
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
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Time necessary for onset sensory and motor block time in minutes
Description
peroperative period
Time Frame
Day 0
Title
Failure of the block: yes/no
Description
perop
Time Frame
Day 0
Title
occurrence of neurological omplications, yes/no
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Cuvillon, PhD
Organizational Affiliation
APHP Pitié Salpetriere
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHP Pitié-Sampetriere
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23348203
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.
Results Reference
derived
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Evaluation of Block Duration in Type 2 Diabetes Patients
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