Effect of Interscalene Block on Ventilatory Function (KTBIS)

January 16, 2015 updated by: Philippe Cuvillon, Pierre and Marie Curie University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75013
        • Centre hospitalier La Pitié Salpetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of the pulmonary maximum forced expiratory flow
Time Frame: Day 2
Outcome measure was performed using a spirometer
Day 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)
Day 2
Pain score at rest and motion
Time Frame: Day 2
Outcome Measure using a visual analog scale (0 to 10)
Day 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of sensory interscalene block
Time Frame: Day 2
outcome measure was performed using a cold test on the skin
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre and Marie Curie University

Investigators

  • Principal Investigator: Philippe Cuvillon, Md,PhD, Caremeau Hospital, Nimes, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 16, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTBIS-2012-V1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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