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Transversus Abdominis Plane Blocks With Abdominoplasty (TAPA)

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Ropivacaine 0.25%, 0.5 ml/kg
Ropivacaine 0.25%, 0.5 ml/kg
Sponsored by
Clinique Saint-Jean, Bruxelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring Transversus abdominis plane block, Ultrasound guided, Abdominoplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Eligible for abdominoplasty
  • ASA 1-2
  • Fluent french/dutch/english

Exclusion Criteria:

  • History of allergy to local anaesthetics
  • Chronic opioids abuse
  • Pregnant patients

Sites / Locations

  • Clinique Saint Jean

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

iTAP-group

aTAP-group

Arm Description

Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle

Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet

Outcomes

Primary Outcome Measures

Morphine consumption
Consumption measured by the use of the PCA pump

Secondary Outcome Measures

VAS score
Post operative nausea and vomiting
Constipation
Pruritus
First time to get up
First time to eat

Full Information

First Posted
January 14, 2011
Last Updated
April 26, 2011
Sponsor
Clinique Saint-Jean, Bruxelles
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1. Study Identification

Unique Protocol Identification Number
NCT01278264
Brief Title
Transversus Abdominis Plane Blocks With Abdominoplasty
Acronym
TAPA
Official Title
Transversus Abdominis Plane Blocks in Patients Scheduled for an Abdominoplasty. A Prospective, Randomized, Double Blind, Comparison Between the Posterior Approach and Placebo.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Clinique Saint-Jean, Bruxelles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparing morphine consumption and recovery with two different TAP block techniques after abdominoplasty.
Detailed Description
TAP blocks have the potential to become an important part of multi-modal analgesia after abdominal surgery (1,2). Originally Dr J McDonnell described a blind double pop technique, trough the triangle of Petit, with up to 48 hours of analgesia (3,4). Dr P Hebbard described an ultrasound based technique with a subcostal (for supra-umbilical analgesia) and an axillary mid-line injection (for sub-umbilical analgesia) in the TAP, with reported analgesia for up to 8 hours (5,6). Recently Dr J McDonnell presented data showing para vertebral spread (up to L5) of the (high dose, low concentration) local anaesthetic explaining the prolonged analgesic effect (7,8). In 2007 Dr Blanco described an ultrasound guided technique for the posterior infiltration as performed by McDonnell (9). Our limited observational comparison between both block techniques confirms this difference. We decided to compare both techniques (the ultrasound guided single shot subcostal injection, the aTAP-group (Hebbard is from Australia) and the ultrasound guided posterior injection, the iTAP-group (McDonnell is from Ireland). We will use the same volume and concentration of local anesthetic and we will asses their analgesic efficacy and improvement in quality of recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Transversus abdominis plane block, Ultrasound guided, Abdominoplasty

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTAP-group
Arm Type
Active Comparator
Arm Description
Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle
Arm Title
aTAP-group
Arm Type
Active Comparator
Arm Description
Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.25%, 0.5 ml/kg
Intervention Description
Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.25%, 0.5 ml/kg
Intervention Description
Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Consumption measured by the use of the PCA pump
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
VAS score
Time Frame
48 hours
Title
Post operative nausea and vomiting
Time Frame
48 hours
Title
Constipation
Time Frame
48 hours
Title
Pruritus
Time Frame
48 hours
Title
First time to get up
Time Frame
48 hours
Title
First time to eat
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligible for abdominoplasty ASA 1-2 Fluent french/dutch/english Exclusion Criteria: History of allergy to local anaesthetics Chronic opioids abuse Pregnant patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud G Bosteels, MD
Phone
02 221 97 62
Ext
0032
Email
Abosteels@clstjean.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud G Bosteels, MD
Organizational Affiliation
Clinique Saint-Jean, Bruxelles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint Jean
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud G Bosteels, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21154380
Citation
Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
Results Reference
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PubMed Identifier
20175754
Citation
Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
Results Reference
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PubMed Identifier
19020158
Citation
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
Results Reference
background
Citation
6. McDonnell J. XXIX Annual ESRA congress - Porto, Portugal, 2010.
Results Reference
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Citation
7. Blanco R. TAP block under ultrasound guidance: the description of a
Results Reference
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PubMed Identifier
20861094
Citation
Griffiths JD, Barron FA, Grant S, Bjorksten AR, Hebbard P, Royse CF. Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block. Br J Anaesth. 2010 Dec;105(6):853-6. doi: 10.1093/bja/aeq255. Epub 2010 Sep 22.
Results Reference
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PubMed Identifier
21148651
Citation
Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.
Results Reference
background
Citation
5. McDonnell J. Ultrasound guided abdominal wall blocks. X Annual BARA meeting -Brussels, Belgium, 2010
Results Reference
background
PubMed Identifier
16418039
Citation
O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available. Erratum In: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added].
Results Reference
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Transversus Abdominis Plane Blocks With Abdominoplasty

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