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

This study has been completed.
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01704612
First received: October 7, 2012
Last updated: December 21, 2012
Last verified: December 2012
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Pierre and Marie Curie University:

Primary Outcome Measures:
  • the duration of sensory block in hours [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    peroperative period

  • Failure of the block: yes/no [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    perop

  • occurrence of neurological omplications, yes/no [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Pierre and Marie Curie University

Additional 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
Study First Received: October 7, 2012
Last Updated: December 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Pierre and Marie Curie University:
local anesthetic
sciatic
diabetes
block
duration

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

ClinicalTrials.gov processed this record on August 19, 2014