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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891540
First Posted: May 1, 2009
Last Update Posted: June 23, 2011
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.
Information provided by:
Hvidovre University Hospital
  Purpose

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 Intervention Phase
Pain, Postoperative Postoperative Nausea and Vomiting Cesarean Section Drug: Ropivacaine Drug: placebo Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

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

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

Estimated Enrollment: 90
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00891540


Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

Responsible Party: Billy B. Kristensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00891540     History of Changes
Other Study ID Numbers: H-C-2009-019
First Submitted: April 30, 2009
First Posted: May 1, 2009
Last Update Posted: June 23, 2011
Last Verified: April 2009

Additional relevant MeSH terms:
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Nausea
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents