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Intra- Versus Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
intraarticular injection with ropivacaine
extraarticular injection with ropivacaine
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • eligible for elective total knee arthroplasty
  • able to speak and understand Danish
  • able to give informed consent

Exclusion Criteria:

  • alocohol or medical abuse
  • allergies to local anesthetics
  • age < 18 yrs.
  • intolerance to opioids

Sites / Locations

  • Hvidovre University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

intraarticular injection with local anesthetic

intracapsular injection with local anesthetic

Outcomes

Primary Outcome Measures

pain

Secondary Outcome Measures

Full Information

First Posted
February 28, 2008
Last Updated
March 17, 2009
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00632580
Brief Title
Intra- Versus Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty
Official Title
Intraartikulær Versus ekstraartikulær Bolus Injektion Med Ropivacain Ved Total knæalloplastik: et Prospektivt, Randomiseret, Dobbeltblindet, Kontrolleret Studie
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
July 2008 (Anticipated)

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 evaluate the optimal site for application of local anesthetics in total knee arthroplasty surgery. The hypothesis is, that improved pain relief is obtained when administering local anesthetics in the tissues sourrounding the knee joint compared to the knee joint itself.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
intraarticular injection with local anesthetic
Arm Title
2
Arm Type
Experimental
Arm Description
intracapsular injection with local anesthetic
Intervention Type
Drug
Intervention Name(s)
intraarticular injection with ropivacaine
Intervention Type
Drug
Intervention Name(s)
extraarticular injection with ropivacaine
Primary Outcome Measure Information:
Title
pain
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: eligible for elective total knee arthroplasty able to speak and understand Danish able to give informed consent Exclusion Criteria: alocohol or medical abuse allergies to local anesthetics age < 18 yrs. intolerance to opioids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lasse Andersen, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lasse Andersen, MD
Phone
+45 36323125
Email
lasse.oestergaard.andersen@hvh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Lasse Andersen, MD

12. IPD Sharing Statement

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Intra- Versus Extraarticular Injection of Ropivacaine in Total Knee Arthroplasty

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