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Evaluation of Block Duration in Type 2 Diabetes Patients

NCT ID: NCT01704612

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes Type 2

Keywords

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local anesthetic sciatic diabetes block duration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Diabete group

Patient with type 2 diabete received 20 mL ropivacaine

Group Type ACTIVE_COMPARATOR

ropivacaine

Intervention Type DRUG

patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve

Control group

no diabete reveived 20 mL ropivacaine

Group Type SHAM_COMPARATOR

ropivacaine

Intervention Type DRUG

patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve

Interventions

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ropivacaine

patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve

Intervention Type DRUG

Other Intervention Names

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naropin

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role collaborator

Pierre and Marie Curie University

OTHER

Sponsor Role lead

Responsible Party

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Philippe Cuvillon

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Cuvillon, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP Pitié Salpetriere

Locations

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APHP Pitié-Sampetriere

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 23348203 (View on PubMed)

Other Identifiers

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2011-PC001

Identifier Type: -

Identifier Source: org_study_id