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Clinical Trials/NCT01743378
NCT01743378
Completed
Not Applicable

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

Hvidovre University Hospital1 site in 1 country48 target enrollmentFebruary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy
Sponsor
Hvidovre University Hospital
Enrollment
48
Locations
1
Primary Endpoint
Total morphine consumption during first 24 hours postoperatively
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Billy B Kristensen

MD

Hvidovre University Hospital

Eligibility 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

Outcomes

Primary Outcomes

Total morphine consumption during first 24 hours postoperatively

Time Frame: At 24 hours postoperatively

Secondary Outcomes

  • Postoperative pain by visual analog scale at(Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively)

Study Sites (1)

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