Effect of TAP Block on Ventilatory Function Following Abd... | NCT01719796

Studies
Effect of TAP Block on Ventilatory Function Following Abdominal Surgery

NCT01719796

Sponsor

Pierre and Marie Curie University

Status

Unknown status

Last Update Posted

Nov 1, 2012Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Laparotomy

Interventions

Regional analgesia infusion

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Oct 24, 2012

First Submission Date that Met QC Criteria

Oct 30, 2012

First Posted Date

Nov 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2012

Last Update Posted Date

Nov 1, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mathieu RAUX, Associate Professor, Pierre and Marie Curie UniversityPrincipal Investigator

Lead Sponsor

Pierre and Marie Curie UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bilateral TAP catheter	Experimental	Ultrasonography guided bilateral TAP catheter insertion.	Procedure: Regional analgesia infusion
No TAP catheter	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regional analgesia infusion	Procedure		Bilateral TAP catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vital capacity		72h

Secondary Outcomes

Measure	Description	Time Frame
maximum forced expiratory flow		72h
analgesic consumption		72h
pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

laparotomy

Exclusion Criteria:

below 18, pregnancy, prisoners

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mathieu RAUX, MD, PhD	Contact	+33142177379		mathieu.raux@psl.aphp.fr
Philippe CUVILLON, MD, PhD	Contact	+33675303395		philippe.cuvillon@chu-nimes.fr

Overall Officials

Name	Affiliation	Role
Mathieu RAUX, MD, PhD	Pierre et Marie Curie University, Paris, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Nîmes	Recruiting	Nîmes			France