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

This study is currently recruiting participants.
Verified October 2012 by Pierre and Marie Curie University
Sponsor:
Information provided by (Responsible Party):
Mathieu RAUX, Pierre and Marie Curie University
ClinicalTrials.gov Identifier:
NCT01719796
First received: October 24, 2012
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Laparotomy
 Procedure: Regional analgesia infusion
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.

Further study details as provided by Pierre and Marie Curie University:

Primary Outcome Measures:
  • vital capacity [ Time Frame: 72h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • maximum forced expiratory flow [ Time Frame: 72h ] [ Designated as safety issue: No ]
  • analgesic consumption [ Time Frame: 72h ] [ Designated as safety issue: No ]
  • pain [ Time Frame: 72h ] [ Designated as safety issue: No ]
    resting pain, assessed using VAS

  • diaphragmatic course [ Time Frame: 72h ] [ Designated as safety issue: No ]
    using ultrasonography


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bilateral TAP catheter
Ultrasonography guided bilateral TAP catheter insertion.
 Procedure: Regional analgesia infusion
No Intervention: No TAP catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laparotomy

Exclusion Criteria:

  • below 18, pregnancy, prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mathieu RAUX, Associate Professor, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT01719796     History of Changes
Other Study ID Numbers: KTAP
Study First Received: October 24, 2012
Last Updated: October 30, 2012
Health Authority: France: Drug Safety National Agency

ClinicalTrials.gov processed this record on May 23, 2013