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:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01504386
First received: December 30, 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 robot-assisted laparoscopic hysterecomy.


Condition Intervention Phase
Hysterectomy
Procedure: 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: 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 ] [ Designated as safety issue: No ]
    Opioid consumption via PCA-pump


Secondary Outcome Measures:
  • Pain during rest and cough [ Time Frame: 1,2,4,8,18 and 24 hours ] [ Designated as safety issue: No ]
    VAS-pain score at rest and at cough

  • Postoperative nausea and vomiting [ Time Frame: 1,2,4,8,18 and 24 hours ] [ Designated as safety issue: No ]
    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

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

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01504386     History of Changes
Other Study ID Numbers: SM1-HT-2011
Study First Received: December 30, 2011
Last Updated: August 21, 2013
Health Authority: Denmark: The National Committee on Health Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on April 16, 2014