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CompletedNCT03206554Updated Jul 2, 2017

Local Infiltration Analgesia in Total Knee Arthroplasty

A Phase 2 interventional study of Ropivacaine and Saline in Total Knee Arthroplasty and Analgesia, sponsored by Asklepieion Voulas General Hospital. Completed. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Sep 2015, registered Jun 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
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Study summary

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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Conditions studied

  • Total Knee Arthroplasty
  • Analgesia

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03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 40 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.

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Lead sponsor

Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    LIA

    Local infiltration analgesia

    Drug: Ropivacaine

  • Sham comparator
    sham LIA

    Saline injections

    Other: Saline

Interventions

  • DrugRopivacaine

    Large volume local anaesthetic intraarticularly

  • OtherSaline

    sham injection

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What researchers measure

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

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

    Time frame: 24 hours

  4. Duration of hospitalization

    Number of days patients remain in the hospital postoperatively

    Time frame: 1 month

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Tziona D, Papaioannou M, Mela A, Potamianou S, Makris A. Local infiltration analgesia combined with a standardized multimodal approach including an adductor canal block in total knee arthroplasty: a prospective randomized, placebo-controlled, double-blinded clinical trial. J Anesth. 2018 Jun;32(3):326-332. doi: 10.1007/s00540-018-2476-x. Epub 2018 Mar 5. PubMed 29508066 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03206554
Lead sponsor
Asklepieion Voulas General Hospital
Responsible party
Alexandros Makris (Consultant Anaesthesiologist, Asklepieion Voulas General Hospital) — Principal investigator
First posted
Jul 2, 2017
Start date
Sep 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Jul 2, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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