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Completed

NCT Number: NCT00562627

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asker and Baerum Hospital

Rud, 1309, Norway

About this study

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:

  • Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
  • Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

intraoperative and 1. postoperative day

Other names: Naropin

Adrenaline

Drug

intraoperative LIA (IV and IA) and continuous EDA

Other names: Adrenalin, (epinephrine)

Ketorolac

Drug

intraoperative and 1. postoperative day

Other names: Toradol

Morphine

Drug

intraoperative

Other names: Morfin

Fentanyl

Drug

continuous postoperatively

Bupivacaine

Drug

continuous postoperatively

Other names: Marcain

Primary outcomes

  1. 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

  1. Opioid Use

    Time frame: 48 hours postoperative

    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.

  2. Time to Readiness for Discharge

    Time frame: up to 10 days postoperative

    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.

Sponsors and collaborators

Lead sponsor

Asker & Baerum Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 22, 2007
Registry last updated
Aug 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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