NCT01719796

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

2.2 years

First QC Date

October 24, 2012

Last Update Submit

October 30, 2012

Conditions

Laparotomy

Outcome Measures

Primary Outcomes (1)

  • vital capacity

    72h

Secondary Outcomes (4)

  • maximum forced expiratory flow

    72h

  • analgesic consumption

    72h

  • pain

    72h

  • diaphragmatic course

    72h

Study Arms (2)

Bilateral TAP catheter

EXPERIMENTAL

Ultrasonography guided bilateral TAP catheter insertion.

Procedure: Regional analgesia infusion

No TAP catheter

NO INTERVENTION

Interventions

Regional analgesia infusionPROCEDURE
Bilateral TAP catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • laparotomy

You may not qualify if:

  • below 18, pregnancy, prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire de Nîmes

Nîmes, France

RECRUITING

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, France

RECRUITING

Study Officials

  • Mathieu RAUX, MD, PhD

    Pierre et Marie Curie University, Paris, France

    STUDY DIRECTOR

Central Study Contacts

Mathieu RAUX, MD, PhD

CONTACT

+33142177379mathieu.raux@psl.aphp.fr

Philippe CUVILLON, MD, PhD

CONTACT

+33675303395philippe.cuvillon@chu-nimes.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 24, 2012

First Posted

November 1, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

FR(2)