Transversus Abdominis Plane Block After Robot-assisted Laparocopic Hysterectomy (TAP-block)

August 21, 2013 updated by: Copenhagen University Hospital at Herlev

Effekt of Transversus Abdominis Plane (TAP) Block After Robot-assisted Laparocopic Hysterectomy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Univerity Hospital, Department of Anaesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAP block
TAP block with ropivacaine
Procedure: TAP block
Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 %
Other Names:
  • 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 Names:
  • Saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid consumption
Time Frame: 0-24 hours
Opioid consumption via PCA-pump
0-24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during rest and cough
Time Frame: 1,2,4,8,18 and 24 hours
VAS-pain score at rest and at cough
1,2,4,8,18 and 24 hours
Postoperative nausea and vomiting
Time Frame: 1,2,4,8,18 and 24 hours
Nausea score 0-3 No. of vomits
1,2,4,8,18 and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Henrik Torup, MD, Herlev University Hospital, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 30, 2011

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Estimate)

August 22, 2013

Last Update Submitted That Met QC Criteria

August 21, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM1-HT-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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