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

This study has been completed.
Information provided by:
Hvidovre University Hospital Identifier:
First received: October 7, 2008
Last updated: June 22, 2011
Last verified: July 2008

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 Intervention Phase
Pain, Postoperative Postoperative Nausea and Vomiting Drug: Ropivacaine 0.5 % Drug: Isotonic NaCl Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

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

Secondary Outcome Measures:
  • PONV [ Time Frame: 32 h ]

Estimated Enrollment: 48
Study Start Date: October 2008
Study Completion Date: December 2010
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 0.5 %
Local Infiltration with Ropivacaine 0.5 %
Placebo Comparator: 2
Local infiltration with Placebo (NaCl)
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 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
  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: NCT00768456

Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

Responsible Party: Billy B Kristensen, Hvidovre University Hospital Identifier: NCT00768456     History of Changes
Other Study ID Numbers: H-C-2008-030
Study First Received: October 7, 2008
Last Updated: June 22, 2011

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on July 27, 2017