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Effect of Interscalene Block on Ventilatory Function (KTBIS)

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ClinicalTrials.gov Identifier: NCT01740453
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Respiratory Depression Anesthesia Morbidity Block Drug: ropivacaine 2 mg/ml Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection
Study Start Date : January 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Single (no catheter)
ropivacaine single injection : 5 mg/ml 15 ml
Experimental: Continuous infusion
Single injection with continuous injection ropivacaine 2 mg/ml 8 ml/h
Drug: ropivacaine 2 mg/ml
single




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Duration of sensory interscalene block [ Time Frame: Day 2 ]
    outcome measure was performed using a cold test on the skin



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01740453


Locations
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France
Centre hospitalier La Pitié Salpetriere
Paris, Ile de France, France, 75013
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
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Principal Investigator: Philippe Cuvillon, Md,PhD Caremeau Hospital, Nimes, France
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Responsible Party: Philippe Cuvillon, MD, PhD, Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01740453    
Other Study ID Numbers: KTBIS-2012-V1
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents