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Effect of TAP Block on Ventilatory Function Following Abdominal Surgery (KTAP)

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ClinicalTrials.gov Identifier: NCT01719796
Recruitment Status : Unknown
Verified October 2012 by Mathieu RAUX, Pierre and Marie Curie University.
Recruitment status was:  Recruiting
First Posted : November 1, 2012
Last Update Posted : November 1, 2012
Sponsor:
Information provided by (Responsible Party):
Mathieu RAUX, Pierre and Marie Curie University

Study Description
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Brief Summary:
Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.

Condition or disease Intervention/treatment Phase
Laparotomy Procedure: Regional analgesia infusion Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.
Study Start Date : October 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Bilateral TAP catheter
Ultrasonography guided bilateral TAP catheter insertion.
 Procedure: Regional analgesia infusion
No Intervention: No TAP catheter


Outcome Measures
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Primary Outcome Measures :
  1. vital capacity [ Time Frame: 72h ]

Secondary Outcome Measures :
  1. maximum forced expiratory flow [ Time Frame: 72h ]
  2. analgesic consumption [ Time Frame: 72h ]
  3. pain [ Time Frame: 72h ]
    resting pain, assessed using VAS

  4. diaphragmatic course [ Time Frame: 72h ]
    using ultrasonography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laparotomy

Exclusion Criteria:

  • below 18, pregnancy, prisoners
Contacts and Locations
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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): NCT01719796


Contacts
Contact: Mathieu RAUX, MD, PhD +33142177379 mathieu.raux@psl.aphp.fr
Contact: Philippe CUVILLON, MD, PhD +33675303395 philippe.cuvillon@chu-nimes.fr

Locations
France
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes, France
Contact: Philippe CUVILLON, MD, PhD    +33675303395    philippe.cuvillon@chu-nimes.fr   
Principal Investigator: Philippe CUVILLON, MD, PhD         
Centre Hospitalier Universitaire de Saint-Etienne Recruiting
Saint-Etienne, France
Contact: Serge MOLLIEX, MD, PhD    +33477120922    serge.molliex@chu-st-etienne.fr   
Principal Investigator: Serge MOLLIEX, MD, PhD         
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
Study Director: Mathieu RAUX, MD, PhD Pierre et Marie Curie University, Paris, France
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Mathieu RAUX, Associate Professor, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT01719796     History of Changes
Other Study ID Numbers: KTAP
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012