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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pharmacological Action
• Intervention / Treatment: Drug: Tranexamic acid intravenous administration; Drug: Saline

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: gülten arslan, Assoc prof; Phone Number: 2176 +905323620366; Email: gulten.arslan@yahoo.com.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: intravenous saline administration
Placebo Comparator: placebo group; The control group will be given intravenous 100 ml of saline	Drug: Saline; Participant was given intravenous 100 ml saline; Other Names: intravenous saline administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used	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.	Change from baseline at 0., 1., 6. hours

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Study Director: Gülten Arslan, DrLutfiKirdar training and research hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: traneksamicanalgesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
   Information identifier: doi: 10.1371

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No