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

NCT06040853 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-09-18

No results posted yet for this study

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).

Conditions

  • Pharmacological Action

Interventions

DRUG

Tranexamic acid intravenous administration

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.

DRUG

Saline

Participant was given intravenous 100 ml saline

Sponsors & Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Gülten Arslan · DrLutfiKirdar training and research hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-02-28
Completion
2024-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06040853 on ClinicalTrials.gov