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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01418144
First received: June 9, 2011
Last updated: August 21, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transversus Abdominis Plane (TAP) Block as Postoperative Pain Management After Laparoscopic Colon Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain during cough [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    VAS-pain score


Secondary Outcome Measures:
  • Pain during rest [ Time Frame: 1,2,4,6,12 and 24 hours ] [ Designated as safety issue: No ]
    VAS-pain score at rest

  • Total opioid consumption [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
    Opioid consumption via PCA-pump.

  • Postoperative nausea and vomiting [ Time Frame: 1,2,4,6,12,18 and 24 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418144

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

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01418144     History of Changes
Other Study ID Numbers: SM1-HT-2010
Study First Received: June 9, 2011
Last Updated: August 21, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on April 17, 2014