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Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study

This study has been completed.
Information provided by:
Hvidovre University Hospital Identifier:
First received: October 7, 2008
Last updated: July 8, 2010
Last verified: October 2008

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 Intervention Phase
Vaginal Prolapse Drug: Ropivacaine Drug: Isotonic NaCl Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

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

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

Estimated Enrollment: 48
Study Start Date: October 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00769054

Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Principal Investigator: Billy B Kristensen, MD Hvidovre University Hospital
  More Information

Responsible Party: Billy B Kristensen, Hvidovre University Hospital Identifier: NCT00769054     History of Changes
Other Study ID Numbers: H-C-2008-035
Study First Received: October 7, 2008
Last Updated: July 8, 2010

Keywords provided by Hvidovre University Hospital:
Postoperative pain

Additional relevant MeSH terms:
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 21, 2017