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Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
pregabalin
Placebo
Etoricoxib
paracetamol
Morphine
Ropivacaine
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing primary total knee arthroplasty

Exclusion Criteria:

  • revision or bilateral arthroplasty, significant renal or hepatic impairment, documented allergy or intolerance to NSAIDs, paracetamol, morphine or pregabalin, chronic pain syndrome treated with chronic opioids, obstructive sleep apnea not treated with continuous positive airway pressure, seizures, breastfeeding, inability to use patient-controlled analgesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    PREGABALIN

    PLACEBO

    Arm Description

    All subjects receive intravenous PCA morphine, paracetamol 1g po six hourly and etoricoxib 120mg po once daily. Subjects receive pregabalin 75mg orally preoperatively followed by 75mg at night for two days. During surgery, patients received general anaesthesia with femoral nerve block on the side of surgery.

    All subjects receive intravenous PCA morphine, paracetamol 1g po six hourly and etoricoxib 120mg po once daily. Subjects receive either placebo tablet (of identical appearance to pregabalin) orally preoperatively followed by 75mg at night for two days. During surgery, patients received general anaesthesia with femoral nerve block on the side of surgery.

    Outcomes

    Primary Outcome Measures

    Cumulative morphine consumption at 72 hours postoperatively

    Secondary Outcome Measures

    Functional scores: SF-36v2 at 3 months and 6 months postoperatively
    Functional scores: Knee Society Score at 3 months and 6 months postoperatively
    Functional scores: WOMAC at 3 months and 6 months postoperatively
    Western Ontario and McMaster Universities Arthritis Index (WOMAC)
    Knee range of motion at 3 months and 6 months postoperatively

    Full Information

    First Posted
    October 20, 2016
    Last Updated
    September 12, 2017
    Sponsor
    National University Hospital, Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02954484
    Brief Title
    Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty
    Official Title
    Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National University Hospital, Singapore

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to provide high quality evidence from a double-blinded, randomized controlled trial on the efficacy of perioperative pregabalin in reducing morphine requirements, improving pain scores and reducing chronic neuropathic pain when compared with placebo for primary total knee arthroplasty. It hence aims to improve on choice of analgesia adjuncts for total knee arthroplasty.
    Detailed Description
    Aims: Whether pregabalin given preoperatively and for one week postoperatively in addition to patient-controlled analgesia (PCA) morphine is effective in reducing morphine requirements, improving pain scores and reducing chronic neuropathic pain when compared with placebo for primary total knee arthroplasty. Methodology: A single-centre double-blind randomized controlled trial in patients undergoing primary total knee arthroplasty. All subjects receive PCA morphine, paracetamol 1g every six hours, etoricoxib 120mg once daily postoperatively. Subjects receive either pregabalin 75mg po preoperatively followed by 75mg OM and 25mg ON for two days postoperatively or matching placebo. The primary outcome is cumulative morphine consumption at 72 hr following surgery. Secondary outcome measures included pain scores, knee range of motion and patient satisfaction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    116 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PREGABALIN
    Arm Type
    Active Comparator
    Arm Description
    All subjects receive intravenous PCA morphine, paracetamol 1g po six hourly and etoricoxib 120mg po once daily. Subjects receive pregabalin 75mg orally preoperatively followed by 75mg at night for two days. During surgery, patients received general anaesthesia with femoral nerve block on the side of surgery.
    Arm Title
    PLACEBO
    Arm Type
    Placebo Comparator
    Arm Description
    All subjects receive intravenous PCA morphine, paracetamol 1g po six hourly and etoricoxib 120mg po once daily. Subjects receive either placebo tablet (of identical appearance to pregabalin) orally preoperatively followed by 75mg at night for two days. During surgery, patients received general anaesthesia with femoral nerve block on the side of surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    pregabalin
    Other Intervention Name(s)
    Lyrica (Pfizer Pte Ltd, Singapore)
    Intervention Description
    see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Manufactured by Beacons Pharmaceuticals Pte Ltd, Singapore.
    Intervention Description
    Placebo capsule containing lactose and MCC (no active ingredients).
    Intervention Type
    Drug
    Intervention Name(s)
    Etoricoxib
    Other Intervention Name(s)
    'Arcoxia'
    Intervention Description
    Etoricoxib 120mg per oral once daily on postoperative days 1,2,3. 'Arcoxia' manufacture site: MSD International GMBH, Singapore
    Intervention Type
    Drug
    Intervention Name(s)
    paracetamol
    Other Intervention Name(s)
    acetaminophen
    Intervention Description
    Paracetamol 1g per oral 6hourly on postoperative days 1,2,3. Manufacture site: SM Pharmaceuticals, Malaysia
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Intervention Description
    patient-controlled analgesia intravenous morphine sulphate on postoperative days 1,2,3. Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Other Intervention Name(s)
    'Naropin'
    Intervention Description
    Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden
    Primary Outcome Measure Information:
    Title
    Cumulative morphine consumption at 72 hours postoperatively
    Time Frame
    72 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Functional scores: SF-36v2 at 3 months and 6 months postoperatively
    Time Frame
    3 months and 6 months postoperatively
    Title
    Functional scores: Knee Society Score at 3 months and 6 months postoperatively
    Time Frame
    3 months and 6 months postoperatively
    Title
    Functional scores: WOMAC at 3 months and 6 months postoperatively
    Description
    Western Ontario and McMaster Universities Arthritis Index (WOMAC)
    Time Frame
    3 months and 6 months postoperatively
    Title
    Knee range of motion at 3 months and 6 months postoperatively
    Time Frame
    3 months and 6 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients undergoing primary total knee arthroplasty Exclusion Criteria: revision or bilateral arthroplasty, significant renal or hepatic impairment, documented allergy or intolerance to NSAIDs, paracetamol, morphine or pregabalin, chronic pain syndrome treated with chronic opioids, obstructive sleep apnea not treated with continuous positive airway pressure, seizures, breastfeeding, inability to use patient-controlled analgesia.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    lingaraj krishna, frcs (Orth)
    Organizational Affiliation
    National University Health System, Singapore
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty

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