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Transversus Abdominis Plane Block After Robot-assisted Laparocopic Hysterectomy (TAP-block)

This study has been terminated.
(Due to local restructering, further recruting was not possible)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504386
First Posted: January 5, 2012
Last Update Posted: August 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
  Purpose
The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after robot-assisted laparoscopic hysterecomy.

Condition Intervention Phase
Hysterectomy Procedure: TAP block Procedure: Placebo TAP block Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effekt of Transversus Abdominis Plane (TAP) Block After Robot-assisted Laparocopic Hysterectomy

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Total opioid consumption [ Time Frame: 0-24 hours ]
    Opioid consumption via PCA-pump


Secondary Outcome Measures:
  • Pain during rest and cough [ Time Frame: 1,2,4,8,18 and 24 hours ]
    VAS-pain score at rest and at cough

  • Postoperative nausea and vomiting [ Time Frame: 1,2,4,8,18 and 24 hours ]
    Nausea score 0-3 No. of vomits


Enrollment: 70
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP block
TAP block with ropivacaine
Procedure: TAP block
Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 %
Other Name: Naropin 0.5%
Placebo Comparator: Placebo TAP block
Sham block with saline
Procedure: Placebo TAP block
Bilateral placement of 20 ml of saline 0.9 % in the transversus abdominis plane
Other Name: Saline 0.9%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80
  • BMI 17-40
  • Written consent
  • Can cooperate

Exclusion Criteria:

  • Drug and alcohol abuse
  • Consumption of opioids
  • Drug allergy
  • Infection at insertion point of needle
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504386


Locations
Denmark
Herlev Univerity Hospital, Department of Anaesthesia
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Henrik Torup, MD Herlev University Hospital, Copenhagen
  More Information

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01504386     History of Changes
Other Study ID Numbers: SM1-HT-2011
First Submitted: December 30, 2011
First Posted: January 5, 2012
Last Update Posted: August 22, 2013
Last Verified: August 2013