Transversus Abdominis Plane Block During Kidney Transplant Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant
• Intervention / Treatment: Drug: Ropivacaine 500mg/100ml Naropeine; Drug: 0.9% sodium chloride BAXTER

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU de Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: 0.9% sodium chloride BAXTER
Experimental: TAP-Bloc	Drug: Ropivacaine 500mg/100ml Naropeine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mesurement of VAS (Visual analogue scale) scores for pain	During the first 24 hours post-op

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of analgesic consomption	During the first 24 hours post-op

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2013
• Primary Completion (Actual): July 9, 2014
• Study Completion (Actual): July 9, 2014

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Jazayeri-Steinmetz AOI 2012