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

NCT ID: NCT00769054

Last Updated: 2010-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vaginal Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Local Infiltration with Ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Local Infiltration Analgesia with 1 % Ropivacaine

2

Local Infiltration with Placebo

Group Type PLACEBO_COMPARATOR

Isotonic NaCl

Intervention Type DRUG

Local Infiltration with NaCl

Interventions

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Ropivacaine

Local Infiltration Analgesia with 1 % Ropivacaine

Intervention Type DRUG

Isotonic NaCl

Local Infiltration with NaCl

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hvidovre University Hospital

Principal Investigators

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Billy B Kristensen, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-C-2008-035

Identifier Type: -

Identifier Source: org_study_id

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