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Completed

NCT Number: NCT01740453

Effect of Interscalene Block on Ventilatory Function

Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment

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Key information

Conditions

Respiratory Depression Anesthesia Morbidity Bites and Stings Block Chemically-Induced Disorders Poisoning Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre hospitalier La Pitié Salpetriere

Paris, Île-de-France Region, 75013, France

About this study

Unilateral pulmonary dysfunction occured after interscalene block due to phrenic nerve paralysis. This reduction induced vital capacity alteration and peek flow reduction.Several studies analysed dysfunction recovery duration after single injection using short (lidocaine)or intermediate (ropivacaine, bupivacaine)local anesthetic drug. Because continuous infusion prolonged block duration, phenic nerve may be also prolonged. However no study with continuous interscalene infusion have been performed for this dysfunction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • surgery : scheduled for elective shoulder surgery
  • available for 1 month of follow up
  • physical status : 1, 2, 3

Exclusion criteria

  • body mass index > 35
  • contraindication for interscalene block (local sepsis, bleeding, allergy, peripheral neuropathy)
  • vital capacity less than 1.5 liters
  • cardiac or renal insufficiency
  • physical status >3, pregnant, weigh less than 50 kg

Treatment and study plan

ropivacaine 2 mg/ml

Drug

single

Primary outcomes

  1. Reduction of the pulmonary forced vital capacity

    Time frame: Day 2

    A 25 % reduction of the pulmonary forced vital capacity is expected and measured using spirometer

Secondary outcomes

  1. Reduction of the pulmonary maximum forced expiratory flow

    Time frame: Day 2

    Outcome measure was performed using a spirometer

  2. Morphine consumption

    Time frame: Day 2

    Additional morphine administration for pain management (morphine intravenous : 1 mg every 7 min when necessary, pain score > 3/10)

  3. Pain score at rest and motion

    Time frame: Day 2

    Outcome Measure using a visual analog scale (0 to 10)

Other outcomes

  1. Duration of sensory interscalene block

    Time frame: Day 2

    outcome measure was performed using a cold test on the skin

Sponsors and collaborators

Lead sponsor

Pierre and Marie Curie University

Other

Registry information

Official study title

Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection

Acronym: KTBIS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 4, 2012
Registry last updated
Jan 19, 2015

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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