Transversus Abdominis Plane Block During Kidney Transplant Surgery

Phase 4

Completed

• Conditions: Kidney Transplant
• Interventions: Drug: Ropivacaine 500mg/100ml Naropeine; Drug: 0.9% sodium chloride BAXTER

• Registration Number: NCT02080728
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-23
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Primary Completion: 2014-07-09
• Study Completion: 2014-07-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP-Bloc	Ropivacaine 500mg/100ml Naropeine	-
Control	0.9% sodium chloride BAXTER	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Measurement of analgesic consomption	During the first 24 hours post-op

Trial Locations

Locations (1)

CHU de DIJON; 🇫🇷 Dijon, France