Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

Pain, Postoperative Clinical Trial

Official title:

Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891540
• Other study ID #: H-C-2009-019
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2009
• Last updated: June 22, 2011
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2009
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cesarean Section
• Pain, Postoperative
• Postoperative Nausea and Vomiting

Intervention

Drug:
• Ropivacaine
Ropivacaine 0.5%
• Ropivacaine
Ropivacaine 0.2%
• placebo
Isotonic NaCl

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain		24 hours	No
Secondary	Postoperative nausea and vomiting (PONV)		24 hours	No