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

Verified by: Asker & Baerum Hospital, August 2011
First Received: November 21, 2007 | Last Updated: August 5, 2011 | Phase: Phase 4 | Start Date: November 2007
Overall Status: Completed | Estimated Enrollment: 102
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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...

Brief Summary

Official Title: “Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty”

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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2009

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: ropivacaine
    • intraoperative and 1. postoperative day
  • Drug: adrenaline
    • intraoperative LIA (IV and IA) and continuous EDA
  • Drug: ketorolac
    • intraoperative and 1. postoperative day
  • Drug: morphine
    • intraoperative
  • Drug: fentanyl
    • continuous postoperatively
  • Drug: bupivacaine
    • continuous postoperatively

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: LIA IV
    • Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
  • Experimental: LIA IA
    • Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
  • Active Comparator: EDA
    • standard continuous epidural analgesia

Outcome Measures for this Clinical Trial

Primary Measures

  • Pain at Rest (VAS)
    • Time Frame: 48 hours postoperative
      Safety Issue?: No

Secondary Measures

  • Opioid Use
    • Time Frame: 48 hours postoperative
      Safety Issue?: No
  • Time to Readiness for Discharge
    • Time Frame: up to 10 days postoperative
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Asker & Baerum Hospital Other

Overall Clinical Trial Officials and Contacts

Ulrich J Spreng, MD Principal Investigator Asker and Baerum Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00562627

Study ID Number: 2007-003030-41

ClinicalTrials.gov Identifier: NCT00562627

Health Authority: Norway: The National Committees for Research Ethics in Norway

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