NCT00905957

Brief Summary

The purpose of this study is to evaluate the efficacy of a local anaesthetic injection in the plane between the abdominal muscles in reducing the amount of pain relief required after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 3, 2022

Status Verified

October 1, 2010

Enrollment Period

8 months

First QC Date

May 19, 2009

Last Update Submit

June 1, 2022

Conditions

Disorder Related to Renal TransplantationPain

Keywords

transversus abdominis plane blockrelief

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption in first 24 hours after renal transplantation

    24 hours

Study Arms (2)

Transversus abdominis plane (TAP) Group

ACTIVE COMPARATOR

Patients will receive a TAP block using a local anaesthetic agent after induction of anaesthesia

Procedure: TAP block

Control Group

PLACEBO COMPARATOR

Patients will receive a TAP block using a placebo after induction of anaesthesia

Procedure: TAP block with placebo

Interventions

TAP blockPROCEDURE

TAP block using 20 ml of a local anaesthetic agent will be used in the treatment group

Transversus abdominis plane (TAP) Group
TAP block with placeboPROCEDURE

TAP block using a placebo after induction of anaesthesia

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • renal transplant recipients
  • to 75 years

You may not qualify if:

  • allergy to local anaesthetics
  • chronic pain
  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Liverpool and Broadgreen University Hospitals

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Related Publications (1)

  • Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28.

    PMID: 24974901DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 3, 2022

Record last verified: 2010-10

Locations

GB(1)