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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
  Purpose

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.

Condition Intervention Phase
Osteoarthritis of the Knee
Drug: ropivacaine
Drug: adrenaline
Drug: ketorolac
Drug: morphine
Drug: fentanyl
Drug: bupivacaine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 102
Study Start Date: November 2007
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIA IV
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
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
Experimental: LIA IA
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
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
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
Other Name: Fentanyl
Drug: bupivacaine
continuous postoperatively
Other Name: Marcain

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562627

Locations
Norway
Asker and Baerum Hospital
Rud, Norway, 1309
Sponsors and Collaborators
Asker & Baerum Hospital
Investigators
Principal Investigator: Ulrich J Spreng, MD Asker and Baerum Hospital
  More Information

No publications provided by Asker & Baerum Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulrich Johannes Spreng, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00562627     History of Changes
Other Study ID Numbers: 2007-003030-41, EudraCT 2007-003030-41, REK 1.2007.1603
Study First Received: November 21, 2007
Results First Received: May 24, 2011
Last Updated: August 5, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:
osteoarthritis
knee arthroplasty
local infiltration analgesia
TKA
epidural analgesia
operation
surgery

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Epinephrine
Epinephryl borate
Fentanyl
Ketorolac
Ketorolac Tromethamine
Morphine
Racepinephrine
Ropivacaine
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 25, 2014