NCT01024868

Brief Summary

For the purpose of assessing the spread of the local anaesthetic after injecting it between abdominal muscles on both sides, the investigators will test if the patient can feel a change in the perception of cold and warm, as well as being pricked with a blunt needle. The investigators will also take several blood samples, together with routine samples, to measure the concentration of the local anesthetic in the blood.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

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

Study Start

First participant enrolled

December 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

May 4, 2010

Status Verified

December 1, 2009

Enrollment Period

3 months

First QC Date

December 2, 2009

Last Update Submit

May 3, 2010

Conditions

Transversus Abdominis Plane Block

Keywords

Transversus Abdominis Plane Block

Study Arms (1)

TAP block

Patients before undergoing laparoscopic or other abdominal surgery

Drug: Ropivacaine 0,5%

Interventions

Ropivacaine 0,5%DRUG

Injection of ropivacaine 0,5% 20 ml bilaterally before surgery

TAP block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing abdominal surgery

You may qualify if:

  • undergo abdominal surgery, eligible for TAP block, over 18, BMI 20-40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev University Hospital

Herlev, 2730, Denmark

Location

Related Publications (2)

  • Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.

    PMID: 22450529DERIVED

  • Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.

    PMID: 22381092DERIVED

Study Officials

  • Ann M Møller, dr. med.

    Herlev Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2010

Last Updated

May 4, 2010

Record last verified: 2009-12

Locations

DK(1)