Transversus Abdominis Plane Block for Analgesia in Renal Transplantation: A Randomised Controlled Trial

Conditions: MedDRA version: 9.1Level: LLTClassification code 10036276Term: Postoperative analgesia
Condition to be investigated - Analgesia requirements in patients having renal transplant surgery. The study proposes to reduce current requirements for morphine post-operatively by the use of a Tranversus Abdominis Plane (TAP) Block. This is a technique of depositing local anaesthetic (bupivacaine) into the plane between the transversus abdominis and internal oblique muscles of the abdominal wall, thus providing analgesia to the area in which the surgery takes place.

Registration Number: EUCTR2008-005657-38-IE

Lead Sponsor: Royal College of Surgeons Ireland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 62

Inclusion Criteria

Renal transplantation surgery
Age 18 years or over
ASA I-III
No allergy to bupivacaine
No allergy to morphine
Able to use a PCA device
Informed consent obtained

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Aged under 18 years
ASA IV-V
Allergy to bupivavcaine
Allergy to morphine
Unable to use a PCA device
No consent obtained

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate, in a renal transplantation population, a reduction in morphine use postoperatively in patients who have received a Transversus Abdominis Plane (TAP) block compared with those who received a placebo block.;Secondary Objective: To measure pain scores at rest and on movement, incidence of post-operative nausea and vomiting, incidence of sedation and incidence of respiratory depression for 24 hrs post-operatively and compare them between the TAP group versus the placebo group.;Primary end point(s): The primary endpoint is total morphine consumption in 24hrs. We expect the group who receive a TAP block to have a reduction in morphine requirements compared with those who receive a placebo block.

Secondary Outcome Measures