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

Phase 4

Not yet recruiting

• Conditions: Pharmacological Action
• Interventions: Drug: Tranexamic acid intravenous administration; Drug: Saline

• Registration Number: NCT06040853
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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

Study Timeline

• Study First Submitted: 2023-04-17
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-14
• Last Update Submitted: 2023-09-14
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18
• Study Start: 2023-09-30
• Primary Completion: 2024-02-28
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tranexamic group	Tranexamic acid intravenous administration	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.
placebo group	Saline	The control group will be given intravenous 100 ml of saline

Primary Outcome Measures

Name	Time	Method
Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,	Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score	Investigators will evaluate VAS score, time of first analgesic requirement, used within 24 hours amount of analgesic,

Secondary Outcome Measures

Name	Time	Method
side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used	Change from baseline at 0., 1., 6. hours	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.