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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

Primary Purpose

Pain, Postoperative, Postoperative Nausea and Vomiting, Cesarean Section

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Ropivacaine
placebo
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Local infiltration with Ropivacaine

Local infiltration with Ropivacaine

Local infiltration with NaCl

Outcomes

Primary Outcome Measures

Postoperative pain

Secondary Outcome Measures

Postoperative nausea and vomiting (PONV)

Full Information

First Posted
April 30, 2009
Last Updated
June 22, 2011
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00891540
Brief Title
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section
Official Title
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Nausea and Vomiting, Cesarean Section

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Local infiltration with Ropivacaine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Local infiltration with Ropivacaine
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Local infiltration with NaCl
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ropivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ropivacaine 0.2%
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Isotonic NaCl
Primary Outcome Measure Information:
Title
Postoperative pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting (PONV)
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section

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