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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 is currently recruiting participants.
Verified December 2012 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Billy B Kristensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01743378
First received: November 13, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Total morphine consumption during first 24 hours postoperatively [ Time Frame: At 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative pain by visual analog scale at [ Time Frame: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Length of hospital stay counted in days

  • Time until mobilization [ Time Frame: First 24 hours postoperatively ] [ Designated as safety issue: No ]
    First mobilization defined as walking on the floor


Estimated Enrollment: 48
Study Start Date: February 2011
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743378

Contacts
Contact: Erik Gade, MD +4523814725 gade@dadlnet.dk
Contact: Jesper Ospina Røjskjær, MD +4523366366 jrpedersen1979@gmail.com

Locations
Denmark
Hvidovre Hospital Recruiting
Hvidovre, Hovedstaden, Denmark, 2650
Contact: Erik Gade, MD     23814725     gade@dadlnet.dk    
Contact: Jesper Ospina Røjskjær, MD     23366366     jrpedersen1979@gmail.com    
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Billy B Kristensen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01743378     History of Changes
Other Study ID Numbers: H-1-2010-068
Study First Received: November 13, 2012
Last Updated: December 4, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on May 23, 2013