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

Phase 4

Completed

• Conditions: Vaginal Prolapse
• Interventions: Drug: Ropivacaine; Drug: Isotonic NaCl

• Registration Number: NCT00769054
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-10
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2010-07-08
• Last Update Posted: 2010-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ropivacaine	Local Infiltration with Ropivacaine
2	Isotonic NaCl	Local Infiltration with Placebo

Primary Outcome Measures

Name	Time	Method
Postoperative Pain during rest, coughing and ambulation	½, 1, 2, 4, 8, 12 and 24 h postoperatively

Secondary Outcome Measures

Name	Time	Method
Postoperative Nausea and Vomitus	½, 1, 2, 4, 8, 12 and 24 h postoperatively

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark