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Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418144
First Posted: August 16, 2011
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 laparoscopic surgery on colon.

Condition Intervention Phase
Laparoscopic Colon Surgery Procedure: Transversus abdominis plane (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: Effect of Transversus Abdominis Plane (TAP) Block as Postoperative Pain Management After Laparoscopic Colon Surgery

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

Primary Outcome Measures:
  • Pain during cough [ Time Frame: 6 hours ]
    VAS-pain score


Secondary Outcome Measures:
  • Pain during rest [ Time Frame: 1,2,4,6,12 and 24 hours ]
    VAS-pain score at rest

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

  • Postoperative nausea and vomiting [ Time Frame: 1,2,4,6,12,18 and 24 hours ]
    Nausea score 0-3 No. of vomits


Enrollment: 80
Study Start Date: August 2010
Study Completion Date: July 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transversus abdominis plane (TAP) block
Transversus abdominis plane (TAP) block with ropivacaine
Procedure: Transversus abdominis plane (TAP) block
Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%
Other Name: Naropin
Placebo Comparator: Block with saline
Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
Procedure: Placebo TAP block
Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
Other Name: Placebo block

  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:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 80
  • BMI 18 - 40
  • ASA 1 - 3
  • Written consent
  • Can cooperate

Exclusion Criteria:

  • Mb Chron and Collitis Ulcerosa
  • Drug and alcohol abuse
  • Pregnancy
  • Consumption of opioids
  • Drug allergy
  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): NCT01418144


Locations
Denmark
Herlev University Hospital, Department of anaesthesia
Copenhagen, Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01418144     History of Changes
Other Study ID Numbers: SM1-HT-2010
First Submitted: June 9, 2011
First Posted: August 16, 2011
Last Update Posted: August 22, 2013
Last Verified: August 2013