Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00769054
NCT00769054
Completed
Phase 4

Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie

Hvidovre University Hospital1 site in 1 country48 target enrollmentOctober 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsVaginal Prolapse
InterventionsRopivacaineIsotonic NaCl
DrugsRopivacaineIsotonic NaCl

Overview

Phase
Phase 4
Intervention
Ropivacaine
Conditions
Vaginal Prolapse
Sponsor
Hvidovre University Hospital
Enrollment
48
Locations
1
Primary Endpoint
Postoperative Pain during rest, coughing and ambulation
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
October 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Arms & Interventions

1

Local Infiltration with Ropivacaine

Intervention: Ropivacaine

2

Local Infiltration with Placebo

Intervention: Isotonic NaCl

Outcomes

Primary Outcomes

Postoperative Pain during rest, coughing and ambulation

Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively

Secondary Outcomes

  • Postoperative Nausea and Vomitus(½, 1, 2, 4, 8, 12 and 24 h postoperatively)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 4
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean SectionPain, PostoperativePostoperative Nausea and VomitingCesarean Section
NCT00891540Hvidovre University Hospital90
Completed
Phase 4
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind StudyPain, PostoperativePostoperative Nausea and Vomiting
NCT00768456Hvidovre University Hospital48
Completed
Phase 4
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee ArthroplastyPostoperative Pain
NCT00408707Hvidovre University Hospital16
Completed
Phase 4
Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus PlaceboPain, Postoperative
NCT00771459Hvidovre University Hospital48
Completed
Not Applicable
Local Infiltration Analgesia Following Total Knee ArthroplastyPostoperative Pain
NCT00799175Region Örebro County48