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

NCT06040853 | Unknown Phase 4

• 1 other identifier: traneksamicanalgesia
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pharmacological Action

Outcome Measures

Primary Outcomes (1)

• 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,

  Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score

Secondary Outcomes (1)

• side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used

  Change from baseline at 0., 1., 6. hours

Study Arms (2)

tranexamic group

EXPERIMENTAL

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.

Drug: Tranexamic acid intravenous administration

placebo group

PLACEBO COMPARATOR

The control group will be given intravenous 100 ml of saline

Drug: Saline

Interventions

Tranexamic acid intravenous administration DRUG

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.

Also known as: intravenous saline administration

tranexamic group

Saline DRUG

Participant was given intravenous 100 ml saline

Also known as: intravenous saline administration

placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Related Publications (1)

• Arslan G, Mammadov NY, Onal C, Mavi F, Geyik FD, Eler Cevik B. Postoperative pain evaluation in laparoscopic radical prostatectomy surgery using tranexamic acid: analgesia?, hyperalgesia?? World J Urol. 2025 May 13;43(1):300. doi: 10.1007/s00345-025-05581-w.

  PMID: 40358732 DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gülten Arslan

  DrLutfiKirdar training and research hospital

  STUDY DIRECTOR

Central Study Contacts

gülten arslan, Assoc prof

CONTACT

+905323620366; gulten.arslan@yahoo.com.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, principal investigator

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: September 18, 2023
• Study Start: September 30, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 30, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share