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Pain Control After Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Regional pain control
Local pain control
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total Knee Arthroplasty, Total Knee Replacement, Outcome, Results, Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Indication to Total Knee Arthroplasty
  • Signed informed consent

Exclusion Criteria:

  • Chronic pain
  • Allergy against local anaesthetics
  • Not understanding study or questionnaires

Sites / Locations

  • Universitätsklinikum Carl Gustav Carus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Regional pain control

Local pain control

Arm Description

Regional pain catheter

Local intraarticular pain catheter

Outcomes

Primary Outcome Measures

pain
Pain on Visual Analog Scale

Secondary Outcome Measures

analgetics
Use of additional analgetics
Mobility
grade of mobility
Function
Knee Society Score
Patient reported outcome
Oxford Knee Score
Quality of Life
EQ 5D

Full Information

First Posted
January 24, 2017
Last Updated
February 11, 2019
Sponsor
Technische Universität Dresden
Collaborators
Mathys Ltd Bettlach
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1. Study Identification

Unique Protocol Identification Number
NCT03032133
Brief Title
Pain Control After Total Knee Arthroplasty
Official Title
Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Mathys Ltd Bettlach

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total Knee Arthroplasty, Total Knee Replacement, Outcome, Results, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional pain control
Arm Type
Active Comparator
Arm Description
Regional pain catheter
Arm Title
Local pain control
Arm Type
Experimental
Arm Description
Local intraarticular pain catheter
Intervention Type
Procedure
Intervention Name(s)
Regional pain control
Intervention Description
Regional pain catheter
Intervention Type
Procedure
Intervention Name(s)
Local pain control
Intervention Description
Local intraarticular pain catheter
Primary Outcome Measure Information:
Title
pain
Description
Pain on Visual Analog Scale
Time Frame
daily until day 7 after surgery
Secondary Outcome Measure Information:
Title
analgetics
Description
Use of additional analgetics
Time Frame
daily until day 7 after surgery
Title
Mobility
Description
grade of mobility
Time Frame
daily until day 7 after surgery
Title
Function
Description
Knee Society Score
Time Frame
preoperative, 3 month, 1 year
Title
Patient reported outcome
Description
Oxford Knee Score
Time Frame
preoperative, 3 month, 1 year
Title
Quality of Life
Description
EQ 5D
Time Frame
preoperative, 3 month, 1 year

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication to Total Knee Arthroplasty Signed informed consent Exclusion Criteria: Chronic pain Allergy against local anaesthetics Not understanding study or questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg Lützner, MD
Organizational Affiliation
TU Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Control After Total Knee Arthroplasty

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