A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty

January 22, 2014 updated by: University of Aarhus

Local Infiltration Analgesia for Total Knee Arthroplasty: Should Ketorolac be Added

The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University

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:

  • Total knee arthroplasty
  • Age > 18
  • Tolerance for study drugs
  • Written informed consent

Exclusion Criteria:

-

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline
Drug: Saline
1 ml infiltration 4 ml intraarticular bolus injection of placebo
ACTIVE_COMPARATOR: Ketorolac
Drug: Ketorolac
30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Consumption
Time Frame: 48 hours after surgery
Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery
48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request
Time Frame: within 48 hours after surgery
within 48 hours after surgery
Pain Intensity Scores During Walking
Time Frame: 6-24 hours postoperatively
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
6-24 hours postoperatively
Home Readiness
Time Frame: time to fulfilment of discharge criteria
Ability to meet discharge criteria (home readiness)
time to fulfilment of discharge criteria
Length of Hospital Stay
Time Frame: From the day of surgery until discharge
From the day of surgery until discharge
Pain Intensity During Daily Activity
Time Frame: 16 weeks after surgery
Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)
16 weeks after surgery

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Kjels Søballe, Professor, Aarhus University Hospital

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

May 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (ESTIMATE)

March 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-003180-39

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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