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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00891540
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : June 23, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Postoperative Nausea and Vomiting Cesarean Section Drug: Ropivacaine Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.
Study Start Date : July 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Local infiltration with Ropivacaine
Drug: Ropivacaine
Ropivacaine 0.5%

Active Comparator: 2
Local infiltration with Ropivacaine
Drug: Ropivacaine
Ropivacaine 0.2%

Placebo Comparator: 3
Local infiltration with NaCl
Drug: placebo
Isotonic NaCl

Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Postoperative nausea and vomiting (PONV) [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00891540

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Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Responsible Party: Billy B. Kristensen, Hvidovre University Hospital Identifier: NCT00891540    
Other Study ID Numbers: H-C-2009-019
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: April 2009
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents