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

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ClinicalTrials.gov Identifier: NCT03657979
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eric STEINMETZ, Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Drug: Ropivacaine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo
Actual Study Start Date : September 5, 2011
Actual Primary Completion Date : August 29, 2012
Actual Study Completion Date : August 29, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ropivacaine
Conventional PCA morphine +TAP-block ropivacaine 0.2%
Drug: Ropivacaine
TAP-block Ropivacaine 0.2% during 48 hours

Placebo Comparator: TAP-block with placebo
Conventional PCA morphine treatment with TAP-block with placebo
Drug: Placebo
TAP-block with placebo




Primary Outcome Measures :
  1. Evaluation of morphine consumption at 24 postoperative hours [ Time Frame: 24 hours ]
    Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours


Secondary Outcome Measures :
  1. Evaluation of Visual Analogue Scale scores at 24 postoperative hours [ Time Frame: 24 hours ]
    Visual Analogue Scale scores statement during the first 24 postoperative hours (minimum pain 0 - maximum pain 10)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657979


Locations
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France
Cardiovascular and thoracic surgery unit, CHU Dijon
Dijon Cedex, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
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Principal Investigator: Claude GIRARD, Professor Anesthesia unit
Principal Investigator: Eric STEINMETZ, Professor Cardiovascular and thoracic surgery unit

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Responsible Party: Eric STEINMETZ, Professor, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03657979     History of Changes
Other Study ID Numbers: 2011-002355-34
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Keywords provided by Eric STEINMETZ, Centre Hospitalier Universitaire Dijon:
analgesia
TAP-block

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents