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Completed

NCT Number: NCT01704612

Evaluation of Block Duration in Type 2 Diabetes 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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

APHP Pitié-Sampetriere

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ropivacaine

Drug

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

Other names: naropin

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. Time necessary for onset sensory and motor block time in minutes

    Time frame: Day 0

    peroperative period

  2. Failure of the block: yes/no

    Time frame: Day 0

    perop

  3. occurrence of neurological omplications, yes/no

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Pierre and Marie Curie University

Other

Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Registry information

Official study title

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

Acronym: Diabeteblock

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 11, 2012
Registry last updated
Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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