NCT03657979

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 5, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2012

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

June 29, 2018

Last Update Submit

September 3, 2018

Conditions

Aortic Aneurysm, Abdominal

Keywords

analgesiaTAP-block

Outcome Measures

Primary Outcomes (1)

  • Evaluation of morphine consumption at 24 postoperative hours

    Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours

    24 hours

Secondary Outcomes (1)

  • Evaluation of Visual Analogue Scale scores at 24 postoperative hours

    24 hours

Study Arms (2)

Ropivacaine

EXPERIMENTAL

Conventional PCA morphine +TAP-block ropivacaine 0.2%

Drug: Ropivacaine

TAP-block with placebo

PLACEBO COMPARATOR

Conventional PCA morphine treatment with TAP-block with placebo

Drug: Placebo

Interventions

RopivacaineDRUG

TAP-block Ropivacaine 0.2% during 48 hours

Ropivacaine
PlaceboDRUG

TAP-block with placebo

TAP-block with placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular and thoracic surgery unit, CHU Dijon

Dijon, 21079, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAgnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Claude GIRARD, Professor

    Anesthesia unit

    PRINCIPAL INVESTIGATOR

  • Eric STEINMETZ, Professor

    Cardiovascular and thoracic surgery unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2018

First Posted

September 5, 2018

Study Start

September 5, 2011

Primary Completion

August 29, 2012

Study Completion

August 29, 2012

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

FR(1)