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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014