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

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00768456
First received: October 7, 2008
Last updated: June 22, 2011
Last verified: July 2008
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 32 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PONV [ Time Frame: 32 h ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768456

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

No publications provided

Responsible Party: Billy B Kristensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00768456     History of Changes
Other Study ID Numbers: H-C-2008-030
Study First Received: October 7, 2008
Last Updated: June 22, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Nausea
Ropivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013