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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00891540
First received: April 30, 2009
Last updated: June 22, 2011
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative nausea and vomiting (PONV) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891540

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

No publications provided

Responsible Party: Billy B. Kristensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00891540     History of Changes
Other Study ID Numbers: H-C-2009-019
Study First Received: April 30, 2009
Last Updated: June 22, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on May 23, 2013