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
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: 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 October 01, 2014