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Postoperative Analgesia in Laminectomy ((PAL))

Primary Purpose

Postoperative Pain, Postoperative Laminectomy Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
550 mg naproxen sodium and 30mg codeine
300 mg paracetamol and 30 mg codeine
placebo tablet
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring naproxen sodium codeine, paracetamol codeine, disk surgery

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery

Exclusion Criteria:

  • were known allergies to any of the drugs used in this study
  • peptic ulcer disease
  • hepatic and renal dysfunction,
  • emergency surgery
  • inability to provide informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    550 mg naproxen sodium and 30mg codeine

    300 mg paracetamol and 30 mg codeine

    Placebo

    Arm Description

    Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.

    Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.

    Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.

    Outcomes

    Primary Outcome Measures

    Contramal consumption
    To assess contramal consumption

    Secondary Outcome Measures

    Side effects
    nausea and vomiting
    Pain intensity
    To assess postoperative pain intensity by visual analog scale

    Full Information

    First Posted
    September 27, 2014
    Last Updated
    December 25, 2014
    Sponsor
    Diskapi Yildirim Beyazit Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02255955
    Brief Title
    Postoperative Analgesia in Laminectomy
    Acronym
    (PAL)
    Official Title
    The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    December 2014 (Anticipated)
    Study Completion Date
    December 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diskapi Yildirim Beyazit Education and Research Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.
    Detailed Description
    Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Postoperative Laminectomy Pain
    Keywords
    naproxen sodium codeine, paracetamol codeine, disk surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    550 mg naproxen sodium and 30mg codeine
    Arm Type
    Experimental
    Arm Description
    Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
    Arm Title
    300 mg paracetamol and 30 mg codeine
    Arm Type
    Active Comparator
    Arm Description
    Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
    Intervention Type
    Drug
    Intervention Name(s)
    550 mg naproxen sodium and 30mg codeine
    Other Intervention Name(s)
    Apranax plus
    Intervention Description
    Postoperative contramal consumption, pain intensity, side effects
    Intervention Type
    Drug
    Intervention Name(s)
    300 mg paracetamol and 30 mg codeine
    Other Intervention Name(s)
    geralgine K
    Intervention Description
    Postoperative contramal consumption, pain intensity, side effects
    Intervention Type
    Drug
    Intervention Name(s)
    placebo tablet
    Intervention Description
    Postoperative contramal consumption, pain intensity, side effects
    Primary Outcome Measure Information:
    Title
    Contramal consumption
    Description
    To assess contramal consumption
    Time Frame
    Postoperative 24 hour
    Secondary Outcome Measure Information:
    Title
    Side effects
    Description
    nausea and vomiting
    Time Frame
    postoperative 24 hour
    Title
    Pain intensity
    Description
    To assess postoperative pain intensity by visual analog scale
    Time Frame
    postoperative 24 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery Exclusion Criteria: were known allergies to any of the drugs used in this study peptic ulcer disease hepatic and renal dysfunction, emergency surgery inability to provide informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reyhan Polat, MD
    Phone
    +905326734310
    Email
    reyhanp9@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reyhan Polat, MD
    Organizational Affiliation
    Ministry of Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Postoperative Analgesia in Laminectomy

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