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

The recruitment status of this study is unknown because the information has not been verified recently.

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

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

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

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 March 03, 2015

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