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Completed

NCT Number: NCT03206554

Local Infiltration Analgesia in Total Knee Arthroplasty

40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. All patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with morphine. Morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.

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Key information

Conditions

Total Knee Arthroplasty Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Physical status according to American Society of Anesthesiologists (ASA) I-III
  • Patients scheduled for total knee arthroplasty

Exclusion criteria

  • Contraindication for central and/or peripheral nervous blockade
  • Reoperation on previous total knee arthroplasty
  • History of allergic or other adverse reactions on the agents used in the study
  • Chronic opioid or gabapentinoid use
  • Serious psychiatric, mental and cognitive disorders
  • Language barrier
  • Difficulty in understanding or using a patient controlled analgesia device

Treatment and study plan

Ropivacaine

Drug

Large volume local anaesthetic intraarticularly

Saline

Other

sham injection

Primary outcomes

  1. Morphine consumption

    Time frame: 24 hours

Secondary outcomes

  1. NRS scores

    Time frame: 24 hours

  2. Complications

    Time frame: 24 hours

  3. Patient satisfaction

    Time frame: 24 hours

    Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No

  4. Duration of hospitalization

    Time frame: 1 month

    Number of days patients remain in the hospital postoperatively

Sponsors and collaborators

Lead sponsor

Asklepieion Voulas General Hospital

Other Gov

Registry information

Official study title

Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2017
Registry last updated
Jul 2, 2017

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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