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Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse: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: NCT00769054
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : July 9, 2010
Information provided by:
Hvidovre University Hospital

Brief Summary:

The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse.

The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.

Condition or disease Intervention/treatment Phase
Vaginal Prolapse Drug: Ropivacaine 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 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie
Study Start Date : October 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

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

Placebo Comparator: 2
Local Infiltration with Placebo
Drug: Isotonic NaCl
Local Infiltration with NaCl

Primary Outcome Measures :
  1. Postoperative Pain during rest, coughing and ambulation [ Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively ]

Secondary Outcome Measures :
  1. Postoperative Nausea and Vomitus [ Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 repair of posterior vaginal wall prolapse
  • 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): NCT00769054

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Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Principal Investigator: Billy B Kristensen, MD Hvidovre University Hospital
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Responsible Party: Billy B Kristensen, Hvidovre University Hospital Identifier: NCT00769054    
Other Study ID Numbers: H-C-2008-035
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: July 9, 2010
Last Verified: October 2008
Keywords provided by Hvidovre University Hospital:
Postoperative pain
Additional relevant MeSH terms:
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Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Pelvic Organ Prolapse
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents