Pain Control After Total Knee Arthroplasty

February 11, 2019 updated by: Technische Universität Dresden

Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication to Total Knee Arthroplasty
  • Signed informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Regional pain control
Regional pain catheter
Procedure: Regional pain control
Regional pain catheter
Experimental: Local pain control
Local intraarticular pain catheter
Procedure: Local pain control
Local intraarticular pain catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: daily until day 7 after surgery
Pain on Visual Analog Scale
daily until day 7 after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgetics
Time Frame: daily until day 7 after surgery
Use of additional analgetics
daily until day 7 after surgery
Mobility
Time Frame: daily until day 7 after surgery
grade of mobility
daily until day 7 after surgery
Function
Time Frame: preoperative, 3 month, 1 year
Knee Society Score
preoperative, 3 month, 1 year
Patient reported outcome
Time Frame: preoperative, 3 month, 1 year
Oxford Knee Score
preoperative, 3 month, 1 year
Quality of Life
Time Frame: preoperative, 3 month, 1 year
EQ 5D
preoperative, 3 month, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

Mathys Ltd Bettlach

Investigators

  • Principal Investigator: Jörg Lützner, MD, TU Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKA pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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