Back to resultsEffect of Interscalene Block on Ventilatory Function (KTBIS)
Primary Purpose
Respiratory Depression, Anesthesia Morbidity, Block
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ropivacaine 2 mg/ml
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Depression
Eligibility 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
Sites / Locations
- Centre hospitalier La Pitié Salpetriere
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Single (no catheter)
Continuous infusion
Arm Description
ropivacaine single injection : 5 mg/ml 15 ml
Single injection with continuous injection ropivacaine 2 mg/ml 8 ml/h
Outcomes
Primary Outcome Measures
Reduction of the pulmonary forced vital capacity
A 25 % reduction of the pulmonary forced vital capacity is expected and measured using spirometer
Secondary Outcome Measures
Reduction of the pulmonary maximum forced expiratory flow
Outcome measure was performed using a spirometer
Morphine consumption
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
Outcome Measure using a visual analog scale (0 to 10)
Full Information
NCT ID
NCT01740453
First Posted
November 26, 2012
Last Updated
January 16, 2015
Sponsor
Pierre and Marie Curie University
1. Study Identification
Unique Protocol Identification Number
NCT01740453
Brief Title
Effect of Interscalene Block on Ventilatory Function
Acronym
KTBIS
Official Title
Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pierre and Marie Curie University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Depression, Anesthesia Morbidity, Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single (no catheter)
Arm Type
No Intervention
Arm Description
ropivacaine single injection : 5 mg/ml 15 ml
Arm Title
Continuous infusion
Arm Type
Experimental
Arm Description
Single injection with continuous injection ropivacaine 2 mg/ml 8 ml/h
Intervention Type
Drug
Intervention Name(s)
ropivacaine 2 mg/ml
Intervention Description
single
Primary Outcome Measure Information:
Title
Reduction of the pulmonary forced vital capacity
Description
A 25 % reduction of the pulmonary forced vital capacity is expected and measured using spirometer
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Reduction of the pulmonary maximum forced expiratory flow
Description
Outcome measure was performed using a spirometer
Time Frame
Day 2
Title
Morphine consumption
Description
Additional morphine administration for pain management (morphine intravenous : 1 mg every 7 min when necessary, pain score > 3/10)
Time Frame
Day 2
Title
Pain score at rest and motion
Description
Outcome Measure using a visual analog scale (0 to 10)
Time Frame
Day 2
Other Pre-specified Outcome Measures:
Title
Duration of sensory interscalene block
Description
outcome measure was performed using a cold test on the skin
Time Frame
Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Cuvillon, Md,PhD
Organizational Affiliation
Caremeau Hospital, Nimes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier La Pitié Salpetriere
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
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Effect of Interscalene Block on Ventilatory Function
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