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Clinical Trials/NCT00891540
NCT00891540
Completed
Phase 4

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

Hvidovre University Hospital1 site in 1 country90 target enrollmentJuly 2009

Overview

Phase
Phase 4
Intervention
Ropivacaine
Conditions
Pain, Postoperative
Sponsor
Hvidovre University Hospital
Enrollment
90
Locations
1
Primary Endpoint
Postoperative pain
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
May 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Arms & Interventions

1

Local infiltration with Ropivacaine

Intervention: Ropivacaine

2

Local infiltration with Ropivacaine

Intervention: Ropivacaine

3

Local infiltration with NaCl

Intervention: placebo

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: 24 hours

Secondary Outcomes

  • Postoperative nausea and vomiting (PONV)(24 hours)

Study Sites (1)

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