TAP-Block in Abdominal Aortic Surgery

Aortic Aneurysm, Abdominal Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657979
• Other study ID #: 2011-002355-34
• Status: Completed
• Phase: Phase 4
• Start date: September 5, 2011
• Est. completion date: August 29, 2012

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 29, 2012
• Est. primary completion date: August 29, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Drug:
• Ropivacaine
TAP-block Ropivacaine 0.2% during 48 hours
• Placebo
TAP-block with placebo

Locations

Country	Name	City	State
France	Cardiovascular and thoracic surgery unit, CHU Dijon	Dijon Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of morphine consumption at 24 postoperative hours	Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours	24 hours
Secondary	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)	24 hours