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

This study has been completed.
Sponsor:
Information provided by:
Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT00562627
First received: November 21, 2007
Last updated: August 5, 2011
Last verified: August 2011

November 21, 2007
August 5, 2011
November 2007
June 2009   (final data collection date for primary outcome measure)
Pain at Rest (VAS) [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.
opioid use [ Time Frame: 48 hours postoperative ]
Complete list of historical versions of study NCT00562627 on ClinicalTrials.gov Archive Site
  • Opioid Use [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
    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.
  • Time to Readiness for Discharge [ Time Frame: up to 10 days postoperative ] [ Designated as safety issue: No ]
    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.
  • Pain [ Time Frame: 48 hours postoperative ]
  • time to discharge [ Time Frame: 10 days postoperative ]
  • Knee injury and osteoarthritis score [ Time Frame: 3 month postoperative ]
  • side effects and complications [ Time Frame: postoperative period ]
Not Provided
Not Provided
 
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: ropivacaine
    intraoperative and 1. postoperative day
    Other Name: Naropin
  • Drug: adrenaline
    intraoperative LIA (IV and IA) and continuous EDA
    Other Names:
    • Adrenalin
    • (epinephrine)
  • Drug: ketorolac
    intraoperative and 1. postoperative day
    Other Name: Toradol
  • Drug: morphine
    intraoperative
    Other Name: Morfin
  • Drug: fentanyl
    continuous postoperatively
    Other Name: Fentanyl
  • Drug: bupivacaine
    continuous postoperatively
    Other Name: Marcain
  • Experimental: LIA IV
    Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
    Interventions:
    • Drug: ropivacaine
    • Drug: adrenaline
    • Drug: ketorolac
    • Drug: morphine
  • Experimental: LIA IA
    Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
    Interventions:
    • Drug: ropivacaine
    • Drug: adrenaline
    • Drug: ketorolac
    • Drug: morphine
  • Active Comparator: EDA
    standard continuous epidural analgesia
    Interventions:
    • Drug: adrenaline
    • Drug: fentanyl
    • Drug: bupivacaine
Spreng UJ, Dahl V, Hjall A, Fagerland MW, Ræder J. High-volume local infiltration analgesia combined with intravenous or local ketorolac+morphine compared with epidural analgesia after total knee arthroplasty. Br J Anaesth. 2010 Nov;105(5):675-82. Epub 2010 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
July 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00562627
2007-003030-41, EudraCT 2007-003030-41, REK 1.2007.1603
No
Ulrich Johannes Spreng, Asker and Baerum Hospital
Asker & Baerum Hospital
Not Provided
Principal Investigator: Ulrich J Spreng, MD Asker and Baerum Hospital
Asker & Baerum Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP