NCT01278264

Brief Summary

Comparing morphine consumption and recovery with two different TAP block techniques after abdominoplasty.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 27, 2011

Status Verified

February 1, 2011

Enrollment Period

11 months

First QC Date

January 14, 2011

Last Update Submit

April 26, 2011

Conditions

Post Operative Pain

Keywords

Transversus abdominis plane blockUltrasound guidedAbdominoplasty

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Consumption measured by the use of the PCA pump

    48 hours

Secondary Outcomes (6)

  • VAS score

    48 hours

  • Post operative nausea and vomiting

    48 hours

  • Constipation

    48 hours

  • Pruritus

    48 hours

  • First time to get up

    48 hours

  • +1 more secondary outcomes

Study Arms (2)

iTAP-group

ACTIVE COMPARATOR

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

Drug: Ropivacaine 0.25%, 0.5 ml/kg

aTAP-group

ACTIVE COMPARATOR

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

Drug: Ropivacaine 0.25%, 0.5 ml/kg

Interventions

Ropivacaine 0.25%, 0.5 ml/kgDRUG

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

iTAP-group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint Jean

Brussels, 1000, Belgium

Location

Related Publications (9)

  • 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.

    PMID: 21154380BACKGROUND

  • 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.

    PMID: 20175754BACKGROUND

  • 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.

    PMID: 19020158BACKGROUND

  • 6. McDonnell J. XXIX Annual ESRA congress - Porto, Portugal, 2010.

    BACKGROUND

  • 7. Blanco R. TAP block under ultrasound guidance: the description of a

    BACKGROUND

  • 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.

    PMID: 20861094BACKGROUND

  • 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.

    PMID: 21148651BACKGROUND

  • 5. McDonnell J. Ultrasound guided abdominal wall blocks. X Annual BARA meeting -Brussels, Belgium, 2010

    BACKGROUND

  • 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.

    PMID: 16418039BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Arnaud G Bosteels, MD

    Clinique Saint-Jean, Bruxelles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnaud G Bosteels, MD

CONTACT

02 221 97 62Abosteels@clstjean.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

April 27, 2011

Record last verified: 2011-02

Locations

BE(1)