Clinical trial NCT06040853: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pharmacological Action
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,
timeFrame: Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score
Secondary outcomes:
measure: side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used
timeFrame: Change from baseline at 0., 1., 6. hours
Other outcomes:
Locations:
Study officials:
affiliation: DrLutfiKirdar training and research hospital
name: Gülten Arslan
role: STUDY_DIRECTOR
References: