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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00891540
Other study ID # H-C-2009-019
Secondary ID
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


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
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