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Tramadol vs.Tramadol With Paracetamol

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tramadol
Paracetamol
Sponsored by
Yeditepe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Disc Herniation focused on measuring Acetaminophen, Tramadol, Discogenic pain, Lumbar Discectomy

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

American Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation.

Exclusion Criteria:

Patients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is ≥30 kg/m2 were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Tramadol

    Tramadol-Paracetamol

    Arm Description

    Group Tramadol patients received tramadol 1 mg kg-1 iv

    Group Tramadol-Paracetamol patients received paracetamol 1 gr iv in addition to tramadol 1 mg kg-1 iv 30 minutes before the end of the operation and after the operation at 6 hour intervals for 24 hours

    Outcomes

    Primary Outcome Measures

    Severity of pain
    Self reported pain intensity

    Secondary Outcome Measures

    Tramadol consumption
    Total tramadol consumption during time frame

    Full Information

    First Posted
    March 20, 2018
    Last Updated
    March 27, 2018
    Sponsor
    Yeditepe University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03482492
    Brief Title
    Tramadol vs.Tramadol With Paracetamol
    Official Title
    Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 20, 2014 (Actual)
    Primary Completion Date
    January 12, 2015 (Actual)
    Study Completion Date
    April 3, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yeditepe University 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
    This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.
    Detailed Description
    Background: Despite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate. Aims: This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery. Study Design: In this study we have randomized 60 patients into two treatment groups. In Group Tramadol patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals. Methods: Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation
    Keywords
    Acetaminophen, Tramadol, Discogenic pain, Lumbar Discectomy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tramadol
    Arm Type
    Active Comparator
    Arm Description
    Group Tramadol patients received tramadol 1 mg kg-1 iv
    Arm Title
    Tramadol-Paracetamol
    Arm Type
    Active Comparator
    Arm Description
    Group Tramadol-Paracetamol patients received paracetamol 1 gr iv in addition to tramadol 1 mg kg-1 iv 30 minutes before the end of the operation and after the operation at 6 hour intervals for 24 hours
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol
    Intervention Description
    Tramadol iv
    Intervention Type
    Drug
    Intervention Name(s)
    Paracetamol
    Intervention Description
    Paracetamol iv
    Primary Outcome Measure Information:
    Title
    Severity of pain
    Description
    Self reported pain intensity
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Tramadol consumption
    Description
    Total tramadol consumption during time frame
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation. Exclusion Criteria: Patients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is ≥30 kg/m2 were excluded from the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neslihan Uztüre, MD
    Organizational Affiliation
    Yeditepe University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26218943
    Citation
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    Tramadol vs.Tramadol With Paracetamol

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