Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study
Sponsor
Hvidovre University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00769054
Collaborator
(none)
48
1
2
12
4
Study Details
Study Description
Brief Summary
The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse.
The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Lokal Infiltrations Analgesi Med Ropivakain 1 % Versus Placebo VED Vaginale Descensusoperationer: ET Prospektivt Randomiseret, Dobbeltblindet, Placebo- Kontrolleret Studie
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Oct 1, 2009
Actual Study Completion Date
:
Oct 1, 2009
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 1 Local Infiltration with Ropivacaine |
Drug: Ropivacaine
Local Infiltration Analgesia with 1 % Ropivacaine
|
Placebo Comparator: 2 Local Infiltration with Placebo |
Drug: Isotonic NaCl
Local Infiltration with NaCl
|
Outcome Measures
Primary Outcome Measures
- Postoperative Pain during rest, coughing and ambulation [½, 1, 2, 4, 8, 12 and 24 h postoperatively]
Secondary Outcome Measures
- Postoperative Nausea and Vomitus [½, 1, 2, 4, 8, 12 and 24 h postoperatively]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
eligible for elective repair of posterior vaginal wall prolapse
-
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hvidovre University Hospital | Copenhagen | Hvidovre | Denmark | 2650 |
Sponsors and Collaborators
- Hvidovre University Hospital
Investigators
- Principal Investigator: Billy B Kristensen, MD, Hvidovre University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00769054
Other Study ID Numbers:
- H-C-2008-035
First Posted:
Oct 8, 2008
Last Update Posted:
Jul 9, 2010
Last Verified:
Oct 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: