Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy. The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2008
Typical duration 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
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 23, 2011
July 1, 2008
1 year
October 7, 2008
June 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
32 h
Secondary Outcomes (1)
PONV
32 h
Study Arms (2)
1
ACTIVE COMPARATORLocal infiltration with Ropivacaine
2
PLACEBO COMPARATORLocal infiltration with Placebo (NaCl)
Interventions
Eligibility Criteria
You may qualify if:
- eligible for elective vaginal hysterectomy
- 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 yrs.
- 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
Condition 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
October 7, 2008
First Posted
October 8, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2009
Study Completion
December 1, 2010
Last Updated
June 23, 2011
Record last verified: 2008-07