Evaluation of Block Duration in Type 2 Diabetes Patients (Diabeteblock)

December 21, 2012 updated by: Philippe Cuvillon, Pierre and Marie Curie University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • APHP Pitié-Sampetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabete group
Patient with type 2 diabete received 20 mL ropivacaine
Drug: ropivacaine
patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve
Other Names:
  • naropin
Sham Comparator: Control group
no diabete reveived 20 mL ropivacaine
Drug: ropivacaine
patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve
Other Names:
  • naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the duration of sensory block in hours
Time Frame: 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
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the duration of motor sciatic block
Time Frame: 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
Day 0

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time necessary for onset sensory and motor block time in minutes
Time Frame: Day 0
peroperative period
Day 0
Failure of the block: yes/no
Time Frame: Day 0
perop
Day 0
occurrence of neurological omplications, yes/no
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre and Marie Curie University

Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Philippe Cuvillon, PhD, APHP Pitié Salpetrière

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 7, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Estimate)

December 24, 2012

Last Update Submitted That Met QC Criteria

December 21, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-PC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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