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

NCT ID: NCT06040853

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-03-30

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

Conditions

Pharmacological Action

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

tranexamic group

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.

Group Type: EXPERIMENTAL

Tranexamic acid intravenous administration

Intervention Type: 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.

placebo group

The control group will be given intravenous 100 ml of saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Participant was given intravenous 100 ml saline

Interventions

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.

Intervention Type: DRUG

Saline

Participant was given intravenous 100 ml saline

Intervention Type: DRUG

Other Intervention Names

intravenous saline administration; intravenous saline administration

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nihan Yaman Mammadov

MD, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülten Arslan

Role: STUDY_DIRECTOR

DrLutfiKirdar training and research hospital

Central Contacts

gülten arslan, Assoc prof

Role: CONTACT

gulten.arslan@yahoo.com.tr

+905323620366 ext. 2176

References

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.

Reference Type: DERIVED

PMID: 40358732 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

traneksamicanalgesia

Identifier Type: -

Identifier Source: org_study_id