Evaluation of Block Duration in Type 2 Diabetes Patients

NCT01704612 | Completed Phase 4 DMC

• 1 other identifier: 2011-PC001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Keywords

local anesthetic; sciatic; diabetes; block; duration

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0

Secondary Outcomes (1)

• the duration of motor sciatic block

  Day 0

Other Outcomes (3)

• Time necessary for onset sensory and motor block time in minutes

  Day 0

• Failure of the block: yes/no

  Day 0

• occurrence of neurological omplications, yes/no

  1 month

Study Arms (2)

Diabete group

ACTIVE COMPARATOR

Patient with type 2 diabete received 20 mL ropivacaine

Drug: ropivacaine

Control group

SHAM COMPARATOR

no diabete reveived 20 mL ropivacaine

Drug: ropivacaine

Interventions

ropivacaine DRUG

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

Also known as: naropin

Control group; Diabete group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age (50 80 yrs) with monofilament test 10 g (\> 4/8)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pierre and Marie Curie University: lead
• Centre Hospitalier Universitaire de Nīmes: collaborator

Study Sites (1)

APHP Pitié-Sampetriere

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 23348203 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Bites and Stings

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Philippe Cuvillon, PhD

  APHP Pitié Salpetriere

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 7, 2012
• First Posted: October 11, 2012
• Study Start: July 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

FR (1)