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

July 8, 2010 updated by: Hvidovre University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Local Infiltration with Ropivacaine
Drug: Ropivacaine
Local Infiltration Analgesia with 1 % Ropivacaine
Placebo Comparator: 2
Local Infiltration with Placebo
Drug: Isotonic NaCl
Local Infiltration with NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative Pain during rest, coughing and ambulation
Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
½, 1, 2, 4, 8, 12 and 24 h postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative Nausea and Vomitus
Time Frame: ½, 1, 2, 4, 8, 12 and 24 h postoperatively
½, 1, 2, 4, 8, 12 and 24 h postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Billy B Kristensen, MD, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 7, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

July 9, 2010

Last Update Submitted That Met QC Criteria

July 8, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-C-2008-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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