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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study

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. Identifier: NCT00768456
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : June 23, 2011
Information provided by:
Hvidovre University Hospital

Brief Summary:

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy.

The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Postoperative Nausea and Vomiting Drug: Ropivacaine 0.5 % Drug: Isotonic NaCl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie
Study Start Date : October 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Local infiltration with Ropivacaine
Drug: Ropivacaine 0.5 %
Local Infiltration with Ropivacaine 0.5 %

Placebo Comparator: 2
Local infiltration with Placebo (NaCl)
Drug: Isotonic NaCl
Local Infiltration with NaCl

Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 32 h ]

Secondary Outcome Measures :
  1. PONV [ Time Frame: 32 h ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • eligible for elective vaginal hysterectomy
  • able to speak and understand Danish
  • able to give informed consent

Exclusion Criteria:

  • alcohol or medical abuse
  • allergies to local anesthetics
  • age < 18 yrs.
  • intolerance to opioids

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 identifier (NCT number): NCT00768456

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Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Responsible Party: Billy B Kristensen, Hvidovre University Hospital Identifier: NCT00768456    
Other Study ID Numbers: H-C-2008-030
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: July 2008
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents