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Clinical Trials/NCT00562627
NCT00562627
Completed
Phase 4

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

Asker & Baerum Hospital1 site in 1 country102 target enrollmentNovember 2007

Overview

Phase
Phase 4
Intervention
ropivacaine
Conditions
Osteoarthritis of the Knee
Sponsor
Asker & Baerum Hospital
Enrollment
102
Locations
1
Primary Endpoint
Pain at Rest (VAS)
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
July 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Asker & Baerum Hospital

Eligibility 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

Arms & Interventions

LIA IV

Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine

Intervention: ropivacaine

LIA IV

Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine

Intervention: adrenaline

LIA IV

Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine

Intervention: ketorolac

LIA IV

Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine

Intervention: morphine

LIA IA

Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine

Intervention: ropivacaine

LIA IA

Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine

Intervention: adrenaline

LIA IA

Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine

Intervention: ketorolac

LIA IA

Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine

Intervention: morphine

EDA

standard continuous epidural analgesia

Intervention: adrenaline

EDA

standard continuous epidural analgesia

Intervention: fentanyl

EDA

standard continuous epidural analgesia

Intervention: bupivacaine

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Opioid Use(48 hours postoperative)
  • Time to Readiness for Discharge(up to 10 days postoperative)

Study Sites (1)

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