Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

Phase 4

Completed

• Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting; Cesarean Section
• Interventions: Drug: placebo; Drug: Ropivacaine

• Registration Number: NCT00891540
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % versus Ropivacaine 0.2 % versus Placebo in patients undergoing elective caesarean section.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Study Start: 2009-07
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• eligible for elective caesarean section
• able to speak and understand Danish
• able to give informed consent

Exclusion Criteria

• alcohol or medical abuse
• allergies to local anesthetics
• age < 18 years
• intolerance to opioids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	placebo	Local infiltration with NaCl
1	Ropivacaine	Local infiltration with Ropivacaine
2	Ropivacaine	Local infiltration with Ropivacaine

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting (PONV)	24 hours

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark