Local Anesthetics After Total Knee Arthroplasty
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
local infiltration analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring pain, local infiltration analgesia
Eligibility Criteria
Inclusion Criteria:
- Able to give informed oral and written consent to participate
- Able to speak Danish
Exclusion Criteria:
- Treatment with opioids
- Body Mass Index > 40
Sites / Locations
Outcomes
Primary Outcome Measures
Visual Analogue Scale pain score
Secondary Outcome Measures
Full Information
NCT ID
NCT00518674
First Posted
August 20, 2007
Last Updated
August 20, 2007
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00518674
Brief Title
Local Anesthetics After Total Knee Arthroplasty
Official Title
Local Anesthetics After Total Knee Arthroplasty: Intra- vs. Extraarticular Administration? A Randomized, Double-Blind, Placebo-Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pain, local infiltration analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
local infiltration analgesia
Intervention Description
local wound infiltration with 30 ml ropivacaine 0.2 % (60 mg)
Primary Outcome Measure Information:
Title
Visual Analogue Scale pain score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to give informed oral and written consent to participate
Able to speak Danish
Exclusion Criteria:
Treatment with opioids
Body Mass Index > 40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lasse Andersen, MD
Organizational Affiliation
Hvidovre University Hospital, Copenhagen, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20301825
Citation
Andersen LO, Kristensen BB, Madsen JL, Otte KS, Husted H, Kehlet H. Wound spread of radiolabeled saline with multi- versus few-hole catheters. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):200-2. doi: 10.1097/aap.0b013e3181c7733d.
Results Reference
derived
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Local Anesthetics After Total Knee Arthroplasty
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