Back to resultsLocal Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study
Primary Purpose
Pain, Postoperative, Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine 0.5 %
Isotonic NaCl
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- eligible for elective vaginal hysterectomy
- able to speak and understand Danish
- able to give informed consent
Exclusion Criteria:
- alcohol or medical abuse
- allergies to local anesthetics
- age < 18 yrs.
- intolerance to opioids
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Local infiltration with Ropivacaine
Local infiltration with Placebo (NaCl)
Outcomes
Primary Outcome Measures
Postoperative pain
Secondary Outcome Measures
PONV
Full Information
NCT ID
NCT00768456
First Posted
October 7, 2008
Last Updated
June 22, 2011
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00768456
Brief Title
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study
Official Title
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 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 % vs. Placebo in patients undergoing vaginal hysterectomy.
The hypothesis is that systematic local infiltration will reduce postoperative 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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Local infiltration with Ropivacaine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Local infiltration with Placebo (NaCl)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5 %
Intervention Description
Local Infiltration with Ropivacaine 0.5 %
Intervention Type
Drug
Intervention Name(s)
Isotonic NaCl
Intervention Description
Local Infiltration with NaCl
Primary Outcome Measure Information:
Title
Postoperative pain
Time Frame
32 h
Secondary Outcome Measure Information:
Title
PONV
Time Frame
32 h
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
eligible for elective vaginal hysterectomy
able to speak and understand Danish
able to give informed consent
Exclusion Criteria:
alcohol or medical abuse
allergies to local anesthetics
age < 18 yrs.
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
Learn more about this trial
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study
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