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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005657-38-IE

Enrollment

Registered

2008-09-09

Start date

2008-11-18

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. MedDRA version: 9.1 Level

Interventions

Product Name: bupivacaine Product Code: bupivacaine Pharmaceutical Form: Injection* INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE CAS Number: 18010407 Concentration unit: % percent Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026