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Completed

NCT Number: NCT02080728

Transversus Abdominis Plane Block During Kidney Transplant Surgery

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.

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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de DIJON

Dijon, 21079, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ropivacaine 500mg/100ml Naropeine

Drug

0.9% sodium chloride BAXTER

Drug

Primary outcomes

  1. Mesurement of VAS (Visual analogue scale) scores for pain

    Time frame: During the first 24 hours post-op

Secondary outcomes

  1. Measurement of analgesic consomption

    Time frame: During the first 24 hours post-op

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Transversus Abdominis Plane Block During Kidney Transplant Surgery: Prospective Controlled Randomized Double-blind Trial Comparing Ropivacaine 0.2% With Placebo.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2014
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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