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

A

Asker & Baerum Hospital

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis of the Knee

Treatments

Drug: fentanyl
Drug: ketorolac
Drug: bupivacaine
Drug: adrenaline
Drug: ropivacaine
Drug: morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT00562627
2007-003030-41
REK 1.2007.1603
EudraCT 2007-003030-41

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

102 participants in 3 patient groups

LIA IV
Experimental group
Description:
Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine
Treatment:
Drug: morphine
Drug: ropivacaine
Drug: adrenaline
Drug: ketorolac
LIA IA
Experimental group
Description:
Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine
Treatment:
Drug: morphine
Drug: ropivacaine
Drug: adrenaline
Drug: ketorolac
EDA
Active Comparator group
Description:
standard continuous epidural analgesia
Treatment:
Drug: fentanyl
Drug: adrenaline
Drug: bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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