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

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00769054
First received: October 7, 2008
Last updated: July 8, 2010
Last verified: October 2008

October 7, 2008
July 8, 2010
October 2008
October 2009   (final data collection date for primary outcome measure)
Postoperative Pain during rest, coughing and ambulation [ Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively ] [ Designated as safety issue: No ]
Pain [ Time Frame: 24 h ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00769054 on ClinicalTrials.gov Archive Site
Postoperative Nausea and Vomitus [ Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively ] [ Designated as safety issue: No ]
PONV [ Time Frame: 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study
Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Vaginal Prolapse
  • Drug: Ropivacaine
    Local Infiltration Analgesia with 1 % Ropivacaine
  • Drug: Isotonic NaCl
    Local Infiltration with NaCl
  • Active Comparator: 1
    Local Infiltration with Ropivacaine
    Intervention: Drug: Ropivacaine
  • Placebo Comparator: 2
    Local Infiltration with Placebo
    Intervention: Drug: Isotonic NaCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00769054
H-C-2008-035
Not Provided
Billy B Kristensen, Hvidovre University Hospital
Hvidovre University Hospital
Not Provided
Principal Investigator: Billy B Kristensen, MD Hvidovre University Hospital
Hvidovre University Hospital
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP