Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study

Phase 4

Completed

• Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting
• Interventions: Drug: Ropivacaine 0.5 %; Drug: Isotonic NaCl

• Registration Number: NCT00768456
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy.

The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-07
• 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: 2010-12
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

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

Inclusion Criteria

• eligible for elective vaginal hysterectomy
• 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 0.5 %	Local infiltration with Ropivacaine
2	Isotonic NaCl	Local infiltration with Placebo (NaCl)

Primary Outcome Measures

Name	Time	Method
Postoperative pain	32 h

Secondary Outcome Measures

Name	Time	Method
PONV	32 h

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark