Local Infiltration Analgesia With Ropivacaine Versus Placebo in Caesarean Section
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Ropivakain 0,2 % Versus Placebo Efter Sectio Caesarea: et Prospektivt, Dobbeltblindet, Placebokontrolleret Studie.
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2009
CompletedFirst Posted
Study publicly available on registry
May 1, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 23, 2011
April 1, 2009
10 months
April 30, 2009
June 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
24 hours
Secondary Outcomes (1)
Postoperative nausea and vomiting (PONV)
24 hours
Study Arms (3)
1
ACTIVE COMPARATORLocal infiltration with Ropivacaine
2
ACTIVE COMPARATORLocal infiltration with Ropivacaine
3
PLACEBO COMPARATORLocal infiltration with NaCl
Interventions
Eligibility Criteria
You may qualify if:
- eligible for elective caesarean section
- able to speak and understand Danish
- able to give informed consent
You may not qualify if:
- alcohol or medical abuse
- allergies to local anesthetics
- age \< 18 years
- intolerance to opioids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hvidovre University Hospital
Copenhagen, Hvidovre, 2650, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 30, 2009
First Posted
May 1, 2009
Study Start
July 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
June 23, 2011
Record last verified: 2009-04