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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743378
First Posted: December 6, 2012
Last Update Posted: August 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Billy B Kristensen, Hvidovre University Hospital
  Purpose

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.


Condition Intervention
Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy Procedure: TAP Block Ropivacaine 0,75 % Procedure: TAP Block Saline 0,9 %

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Billy B Kristensen, Hvidovre University Hospital:

Primary Outcome Measures:
  • Total morphine consumption during first 24 hours postoperatively [ Time Frame: At 24 hours postoperatively ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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

  • Length of stay [ Time Frame: First 72 hours after surgery ]
    Length of hospital stay counted in days

  • Time until mobilization [ Time Frame: First 24 hours postoperatively ]
    First mobilization defined as walking on the floor


Enrollment: 48
Study Start Date: February 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 %

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743378


Locations
Denmark
Hvidovre Hospital
Hvidovre, Hovedstaden, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

Responsible Party: Billy B Kristensen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01743378     History of Changes
Other Study ID Numbers: H-1-2010-068
First Submitted: November 13, 2012
First Posted: December 6, 2012
Last Update Posted: August 30, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents