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

Primary Purpose

Vaginal Prolapse

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Isotonic NaCl
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vaginal Prolapse focused on measuring Postoperative pain, PONV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Local Infiltration with Ropivacaine

Local Infiltration with Placebo

Outcomes

Primary Outcome Measures

Postoperative Pain during rest, coughing and ambulation

Secondary Outcome Measures

Postoperative Nausea and Vomitus

Full Information

First Posted
October 7, 2008
Last Updated
July 8, 2010
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00769054
Brief Title
Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study
Official Title
Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Prolapse
Keywords
Postoperative pain, PONV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Local Infiltration with Ropivacaine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Local Infiltration with Placebo
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Local Infiltration Analgesia with 1 % Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Isotonic NaCl
Intervention Description
Local Infiltration with NaCl
Primary Outcome Measure Information:
Title
Postoperative Pain during rest, coughing and ambulation
Time Frame
½, 1, 2, 4, 8, 12 and 24 h postoperatively
Secondary Outcome Measure Information:
Title
Postoperative Nausea and Vomitus
Time Frame
½, 1, 2, 4, 8, 12 and 24 h postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Billy B Kristensen, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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