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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704612
First Posted: October 11, 2012
Last Update Posted: December 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes
  Purpose
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.

Condition Intervention Phase
Diabetes Type 2 Drug: ropivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Subgluteal Sciatic Nerve Block Duration in Type-2 Diabetic and Non Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Time necessary for onset sensory and motor block time in minutes [ Time Frame: Day 0 ]
    peroperative period

  • Failure of the block: yes/no [ Time Frame: Day 0 ]
    perop

  • occurrence of neurological omplications, yes/no [ Time Frame: 1 month ]

Enrollment: 70
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: naropin

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

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704612


Locations
France
APHP Pitié-Sampetriere
Paris, France, 75013
Sponsors and Collaborators
Pierre and Marie Curie University
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Philippe Cuvillon, PhD APHP Pitié Salpetriere
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philippe Cuvillon, MD, PhD, Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01704612     History of Changes
Other Study ID Numbers: 2011-PC001
First Submitted: October 7, 2012
First Posted: October 11, 2012
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes:
local anesthetic
sciatic
diabetes
block
duration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents