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

October 30, 2012 updated by: Mathieu RAUX, Pierre and Marie Curie University

Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

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
      • Nîmes, France
        • Recruiting
        • Centre Hospitalier Universitaire de Nîmes
        • Contact:
        • Principal Investigator:
          • Philippe CUVILLON, MD, PhD
      • Saint-Etienne, France
        • Recruiting
        • Centre Hospitalier Universitaire de Saint-Etienne
        • Contact:
        • Principal Investigator:
          • Serge MOLLIEX, MD, PhD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • laparotomy

Exclusion Criteria:

  • below 18, pregnancy, prisoners

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral TAP catheter
Ultrasonography guided bilateral TAP catheter insertion.
Procedure: Regional analgesia infusion
No Intervention: No TAP catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
vital capacity
Time Frame: 72h
72h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum forced expiratory flow
Time Frame: 72h
72h
analgesic consumption
Time Frame: 72h
72h
pain
Time Frame: 72h
resting pain, assessed using VAS
72h
diaphragmatic course
Time Frame: 72h
using ultrasonography
72h

Collaborators and Investigators

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

Sponsor

Pierre and Marie Curie University

Investigators

  • Study Director: Mathieu RAUX, MD, PhD, Pierre et Marie Curie University, Paris, 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

October 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 24, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2012

Last Update Submitted That Met QC Criteria

October 30, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • KTAP

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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