search
Back to results

TAP-Block in Abdominal Aortic Surgery (TAP-CACAO)

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Ropivacaine
Placebo
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring analgesia, TAP-block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Open abdominal aortic surgery (aneurysm or aortobifemoral bypass)
  • Person who has given his written consent

Exclusion Criteria:

  • Emergency surgery
  • Patient with infection
  • Use of opioids in the long term
  • History of chronic pain
  • Higher functions incompatible with the functioning of the PCA
  • Patients under guardianship

Sites / Locations

  • Cardiovascular and thoracic surgery unit, CHU Dijon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

TAP-block with placebo

Arm Description

Conventional PCA morphine +TAP-block ropivacaine 0.2%

Conventional PCA morphine treatment with TAP-block with placebo

Outcomes

Primary Outcome Measures

Evaluation of morphine consumption at 24 postoperative hours
Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours

Secondary Outcome Measures

Evaluation of Visual Analogue Scale scores at 24 postoperative hours
Visual Analogue Scale scores statement during the first 24 postoperative hours (minimum pain 0 - maximum pain 10)

Full Information

First Posted
June 29, 2018
Last Updated
September 3, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
search

1. Study Identification

Unique Protocol Identification Number
NCT03657979
Brief Title
TAP-Block in Abdominal Aortic Surgery
Acronym
TAP-CACAO
Official Title
Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 5, 2011 (Actual)
Primary Completion Date
August 29, 2012 (Actual)
Study Completion Date
August 29, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal
Keywords
analgesia, TAP-block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
Conventional PCA morphine +TAP-block ropivacaine 0.2%
Arm Title
TAP-block with placebo
Arm Type
Placebo Comparator
Arm Description
Conventional PCA morphine treatment with TAP-block with placebo
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
TAP-block Ropivacaine 0.2% during 48 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAP-block with placebo
Primary Outcome Measure Information:
Title
Evaluation of morphine consumption at 24 postoperative hours
Description
Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Evaluation of Visual Analogue Scale scores at 24 postoperative hours
Description
Visual Analogue Scale scores statement during the first 24 postoperative hours (minimum pain 0 - maximum pain 10)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Open abdominal aortic surgery (aneurysm or aortobifemoral bypass) Person who has given his written consent Exclusion Criteria: Emergency surgery Patient with infection Use of opioids in the long term History of chronic pain Higher functions incompatible with the functioning of the PCA Patients under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude GIRARD, Professor
Organizational Affiliation
Anesthesia unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric STEINMETZ, Professor
Organizational Affiliation
Cardiovascular and thoracic surgery unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular and thoracic surgery unit, CHU Dijon
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Learn more about this trial

TAP-Block in Abdominal Aortic Surgery

We'll reach out to this number within 24 hrs