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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Pierre and Marie Curie University.
Recruitment status was:  Recruiting
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
  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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laparotomy

Exclusion Criteria:

  • below 18, pregnancy, prisoners
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719796

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, France
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
Study Director: Mathieu RAUX, MD, PhD Pierre et Marie Curie University, Paris, France
  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 
Study First Received: October 24, 2012
Last Updated: October 30, 2012
Health Authority: France: Drug Safety National Agency

ClinicalTrials.gov processed this record on December 02, 2016