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

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. Identifier: NCT01504386
Recruitment Status : Terminated (Due to local restructering, further recruting was not possible)
First Posted : January 5, 2012
Last Update Posted : August 22, 2013
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

Brief Summary:
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 or disease Intervention/treatment Phase
Hysterectomy Procedure: TAP block Procedure: Placebo TAP block Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
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
Study Start Date : December 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
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%

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

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01504386

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Herlev Univerity Hospital, Department of Anaesthesia
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
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Principal Investigator: Henrik Torup, MD Herlev University Hospital, Copenhagen
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Responsible Party: Copenhagen University Hospital at Herlev Identifier: NCT01504386    
Other Study ID Numbers: SM1-HT-2011
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents