search
Back to results

Local Infiltration Analgesia in Total Knee Arthroplasty

Primary Purpose

Total Knee Arthroplasty, Analgesia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
Asklepieion Voulas General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    LIA

    sham LIA

    Arm Description

    Local infiltration analgesia

    Saline injections

    Outcomes

    Primary Outcome Measures

    Morphine consumption

    Secondary Outcome Measures

    NRS scores
    Complications
    Patient satisfaction
    Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No
    Duration of hospitalization
    Number of days patients remain in the hospital postoperatively

    Full Information

    First Posted
    June 28, 2017
    Last Updated
    June 30, 2017
    Sponsor
    Asklepieion Voulas General Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03206554
    Brief Title
    Local Infiltration Analgesia in Total Knee Arthroplasty
    Official Title
    Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (Actual)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Asklepieion Voulas General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Total Knee Arthroplasty, Analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LIA
    Arm Type
    Active Comparator
    Arm Description
    Local infiltration analgesia
    Arm Title
    sham LIA
    Arm Type
    Sham Comparator
    Arm Description
    Saline injections
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Intervention Description
    Large volume local anaesthetic intraarticularly
    Intervention Type
    Other
    Intervention Name(s)
    Saline
    Intervention Description
    sham injection
    Primary Outcome Measure Information:
    Title
    Morphine consumption
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    NRS scores
    Time Frame
    24 hours
    Title
    Complications
    Time Frame
    24 hours
    Title
    Patient satisfaction
    Description
    Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No
    Time Frame
    24 hours
    Title
    Duration of hospitalization
    Description
    Number of days patients remain in the hospital postoperatively
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29508066
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Local Infiltration Analgesia in Total Knee Arthroplasty

    We'll reach out to this number within 24 hrs