NCT02080728

Brief Summary

The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo. This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above. This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant 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 Jul 2013

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

July 23, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2014

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

12 months

First QC Date

March 5, 2014

Last Update Submit

December 20, 2018

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • Mesurement of VAS (Visual analogue scale) scores for pain

    During the first 24 hours post-op

Secondary Outcomes (1)

  • Measurement of analgesic consomption

    During the first 24 hours post-op

Study Arms (2)

TAP-Bloc

EXPERIMENTAL
Drug: Ropivacaine 500mg/100ml Naropeine

Control

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride BAXTER

Interventions

Ropivacaine 500mg/100ml NaropeineDRUG
TAP-Bloc
0.9% sodium chloride BAXTERDRUG
Control

Eligibility Criteria

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

You may qualify if:

  • Patient opéré for kidney transplant
  • Patients who have provided written informed consent
  • Patients with national health insurance cover
  • Patients aged 18 years and above

You may not qualify if:

  • Pregnant or breast-feeding women
  • allergies/hypersensitivity to paracetamol (or propacetamol chlorhydrate (paracetamol pro-drug) or one of its excipients), to local anesthetics, morphines (or other constituents)
  • patients under guardianship or ward of court

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 6, 2014

Study Start

July 23, 2013

Primary Completion

July 9, 2014

Study Completion

July 9, 2014

Last Updated

December 21, 2018

Record last verified: 2018-12

Locations

FR(1)