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Effect of Interscalene Block on Ventilatory Function (KTBIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 26, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date January 19, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Reduction of the pulmonary maximum forced expiratory flow [ Time Frame: Day 2 ]
    Outcome measure was performed using a spirometer
  • 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)
  • Pain score at rest and motion [ Time Frame: Day 2 ]
    Outcome Measure using a visual analog scale (0 to 10)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 30, 2012)
Duration of sensory interscalene block [ Time Frame: Day 2 ]
outcome measure was performed using a cold test on the skin
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Interscalene Block on Ventilatory Function
Official Title  ICMJE Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Respiratory Depression
  • Anesthesia Morbidity
  • Block
Intervention  ICMJE Drug: ropivacaine 2 mg/ml
single
Study Arms  ICMJE
  • 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
    Intervention: Drug: ropivacaine 2 mg/ml
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2012)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740453
Other Study ID Numbers  ICMJE KTBIS-2012-V1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes
Study Sponsor  ICMJE Pierre and Marie Curie University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe Cuvillon, Md,PhD Caremeau Hospital, Nimes, France
PRS Account Pierre and Marie Curie University
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP