Transversus Abdominis Plane Block During Kidney Transplant Surgery

Kidney Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080728
• Other study ID #: Jazayeri-Steinmetz AOI 2012
• Status: Completed
• Phase: Phase 4
• Start date: July 23, 2013
• Est. completion date: July 9, 2014

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 9, 2014
• Est. primary completion date: July 9, 2014
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Ropivacaine 500mg/100ml Naropeine

• 0.9% sodium chloride BAXTER

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mesurement of VAS (Visual analogue scale) scores for pain		During the first 24 hours post-op
Secondary	Measurement of analgesic consomption		During the first 24 hours post-op