Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

August 5, 2011 updated by: Asker & Baerum Hospital

Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

The aim of this study is to:

  1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
  2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:

  1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
  2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Study Type

Interventional

Enrollment (Actual)

102

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

  • Norway
      • Rud, Norway, 1309
        • Asker and Baerum Hospital

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:

  • patients at least 18 years of age
  • scheduled for elective total knee arthroplasty
  • ASA I-III
  • signed written informed consent

Exclusion Criteria:

  • age < 18
  • ASA > III
  • moderate or severe cardiac disease, bronchial asthma
  • allergy against ropivacaine, ketorolac or morphine
  • analgetic abuse
  • pregnancy or nursing women
  • severe psychiatric disease
  • moderate to severe dementia

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIA IV
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
Drug: ropivacaine
intraoperative and 1. postoperative day
Other Names:
  • Naropin
Drug: adrenaline
intraoperative LIA (IV and IA) and continuous EDA
Other Names:
  • Adrenalin
  • (epinephrine)
Drug: ketorolac
intraoperative and 1. postoperative day
Other Names:
  • Toradol
Drug: morphine
intraoperative
Other Names:
  • Morfin
Experimental: LIA IA
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
Drug: ropivacaine
intraoperative and 1. postoperative day
Other Names:
  • Naropin
Drug: adrenaline
intraoperative LIA (IV and IA) and continuous EDA
Other Names:
  • Adrenalin
  • (epinephrine)
Drug: ketorolac
intraoperative and 1. postoperative day
Other Names:
  • Toradol
Drug: morphine
intraoperative
Other Names:
  • Morfin
Active Comparator: EDA
standard continuous epidural analgesia
Drug: adrenaline
intraoperative LIA (IV and IA) and continuous EDA
Other Names:
  • Adrenalin
  • (epinephrine)
Drug: fentanyl
continuous postoperatively
Drug: bupivacaine
continuous postoperatively
Other Names:
  • Marcain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at Rest (VAS)
Time Frame: 48 hours postoperative
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
48 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Use
Time Frame: 48 hours postoperative
Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.
48 hours postoperative
Time to Readiness for Discharge
Time Frame: up to 10 days postoperative
Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.
up to 10 days postoperative

Collaborators and Investigators

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

Sponsor

Asker & Baerum Hospital

Investigators

  • Principal Investigator: Ulrich J Spreng, MD, Asker and Baerum Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 5, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-003030-41
  • EudraCT 2007-003030-41
  • REK 1.2007.1603

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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