Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial

August 28, 2013 updated by: Billy B Kristensen, Hvidovre University Hospital

A Prospective double-blinded randomized clinical trial to test the effect of transversus abdominis plane block on postoperative pain and opoid consumption after abdominal hysterectomy.

Two groups of each 24 patients. All patients are given general anesthesia. The patients are randomized to have a ultrasound guided bilateral transversus abdominis plane block with either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided with a PCA for self administration of morphine.

Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively as well as the total consumption of morphine after 24 hours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

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
    • Hovedstaden
      • Hvidovre, Hovedstaden, Denmark, 2650
        • Hvidovre Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Assigned to elective abdominal hysterectomy
  • Must be able to understand and speak danish
  • Must be able to give verbal and written consent

Exclusion Criteria:

  • Abuse of alcohol or medicin
  • Daily treatment with opoids or glucocorticoids
  • Allergy towards any kind of localanesthetic drug
  • Intolerance toward morphine
  • Psychiatric desease
  • Age below 18

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 Ropivacaine 0,75 %
Bilateral Transversus Abdominis Plane Block with 2 x 20 ml Ropivacaine 0,75 %
Procedure: TAP Block Ropivacaine 0,75 %
Placebo Comparator: TAP Block Saline 0,9 %
Bilateral Transversus abdominis plane block with 2 x 20 ml Saline 0,9 %
Procedure: TAP Block Saline 0,9 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total morphine consumption during first 24 hours postoperatively
Time Frame: At 24 hours postoperatively
At 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain by visual analog scale at
Time Frame: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively
Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators at rest, when coughing and when walking
Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively
Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively by one of the investigators
Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively
Length of stay
Time Frame: First 72 hours after surgery
Length of hospital stay counted in days
First 72 hours after surgery
Time until mobilization
Time Frame: First 24 hours postoperatively
First mobilization defined as walking on the floor
First 24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

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

February 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2010-068

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.

Clinical Trials on Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy

Clinical Trials on TAP Block Ropivacaine 0,75 %

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe