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Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?

Primary Purpose

Pharmacological Action

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic acid intravenous administration
Saline
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharmacological Action

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Elective laparoscopic radical prostatectomy will be performed; Surgeon with more than 10 years of laparoscopic prostatectomy experience Participant BMI(weight/height2)(kg/m2)<35 ASA2-3 Participant Age>18 Participant Age<75 Exclusion Criteria: Coagulation disorder, Chronic renal failure, Patients allergic to tranexamic acid, Participant Age<18 Participant Age>75, Participant BMI(weight/height2)(kg/m2)>35, Surgeon with less than 10 years of laparoscopic prostatectomy experience, Patients who had a cerebral, coronary and thromboembolic event within 6 months before the operation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    tranexamic group

    placebo group

    Arm Description

    After intubation, intravenous 15mg/kg tranexamic acid will be given to the study group 10 minutes before the incision and 100 mg/h infusion will be administered until the skin is closed.

    The control group will be given intravenous 100 ml of saline

    Outcomes

    Primary Outcome Measures

    Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,
    Investigators will evaluate VAS score, time of first analgesic requirement, used within 24 hours amount of analgesic,

    Secondary Outcome Measures

    side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used
    Investigators will evaluate demographic characteristics [years, female/male, weight(kg),height(meter), BMI (kg/m2 )], side effect, 0,1,6 st hour hemogram value, amount of antiemetic used.

    Full Information

    First Posted
    April 17, 2023
    Last Updated
    September 14, 2023
    Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06040853
    Brief Title
    Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?
    Official Title
    Evaluation of Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2024 (Anticipated)
    Study Completion Date
    March 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a surgery that significantly reduces disease-related mortality. The laparoscopic technique, on the other hand, is preferred because it shortens the hospital stay, faster recovery and less postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic effects of tranexamic acid, which is widely used in the management of bleeding in trauma, orthopedic, genitourinary and gynecological surgeries. Routine noninvasive monitoring (ECG, Spo2, NIBP) will be performed when participatient are taken to the operating table without premedication. After midazolam is administered, intubation will be performed by administering 1mg/kg lidocaine, 3mg/kg propofol, 2mcg/kg fentanyl, 0.6mg/kg rocuronium. Anesthesia will be maintained with desflurane with a MAC of 1. A 0.1-0.5 mcg/kg/min remifentanil infusion will be administered by targeting 40-60 values with BIS monitoring. After intubation, 15mg/kg tranexamic acid will be given 10 minutes before the incision, and 100 mg/h infusion will be administered until the skin is closed. The control group will be given 100 ml of saline.1mg/kg tramadol and 1gr parol will be administered 30 minutes before the end of the operation. The primary objectives of the study were to learn the VAS (Visual analog scale) score at 0.6,12, 24,48,72 hours, time to first analgesic requirement, and analgesic requirement within 24 hours. Secondary purposes are to determine the amount of antiemetic used, at the beginning of the operation, Hg at the first hour and postoperative 6 hours, complications and side effects (such as DVT, pulmonary embolism).
    Detailed Description
    Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a surgery that significantly reduces disease-related mortality. The laparoscopic technique, on the other hand, is preferred because it shortens the hospital stay, faster recovery and less postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic effects of tranexamic acid, which is widely used in the management of bleeding in trauma, orthopedic, genitourinary and gynecological surgeries

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pharmacological Action

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tranexamic group
    Arm Type
    Experimental
    Arm Description
    After intubation, intravenous 15mg/kg tranexamic acid will be given to the study group 10 minutes before the incision and 100 mg/h infusion will be administered until the skin is closed.
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    The control group will be given intravenous 100 ml of saline
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid intravenous administration
    Other Intervention Name(s)
    intravenous saline administration
    Intervention Description
    Participants will be given 15mg/kg tranexamic acid before the incision in ten minutes, 100 mg/h will continue until the end of the surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Other Intervention Name(s)
    intravenous saline administration
    Intervention Description
    Participant was given intravenous 100 ml saline
    Primary Outcome Measure Information:
    Title
    Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,
    Description
    Investigators will evaluate VAS score, time of first analgesic requirement, used within 24 hours amount of analgesic,
    Time Frame
    Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score
    Secondary Outcome Measure Information:
    Title
    side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used
    Description
    Investigators will evaluate demographic characteristics [years, female/male, weight(kg),height(meter), BMI (kg/m2 )], side effect, 0,1,6 st hour hemogram value, amount of antiemetic used.
    Time Frame
    Change from baseline at 0., 1., 6. hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elective laparoscopic radical prostatectomy will be performed; Surgeon with more than 10 years of laparoscopic prostatectomy experience Participant BMI(weight/height2)(kg/m2)<35 ASA2-3 Participant Age>18 Participant Age<75 Exclusion Criteria: Coagulation disorder, Chronic renal failure, Patients allergic to tranexamic acid, Participant Age<18 Participant Age>75, Participant BMI(weight/height2)(kg/m2)>35, Surgeon with less than 10 years of laparoscopic prostatectomy experience, Patients who had a cerebral, coronary and thromboembolic event within 6 months before the operation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    gülten arslan, Assoc prof
    Phone
    +905323620366
    Ext
    2176
    Email
    gulten.arslan@yahoo.com.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gülten Arslan
    Organizational Affiliation
    DrLutfiKirdar training and research hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://pubmed.ncbi.nlm.nih.gov/28282425/
    Available IPD/Information Identifier
    doi: 10.1371

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