Pharmacological ActionPhase 4NCT06040853
Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?
A Phase 4 study testing Tranexamic acid intravenous administration and Saline in people with Pharmacological Action, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Tranexamic acid intravenous administration and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 30 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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
- Being tested
- Tranexamic acid intravenous administration, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid intravenous administrationDrug
Also called intravenous saline 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.
SalineDrug
Also called intravenous saline administration
Participant was given intravenous 100 ml saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tranexamic acid intravenous administration |
| placebo group | Placebo comparator | The control group will be given intravenous 100 ml of saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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
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.
Measured: Change from baseline at 0., 1., 6. hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start30 Sep 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nihan Yaman Mammadov, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Gülten Arslan, Study director, DrLutfiKirdar training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040853
- Sponsor's protocol ID
- traneksamicanalgesia
- Status last verified
- Sep 2023
- First submitted
- 17 Apr 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40358732
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?
- ClinicalTrials.gov ID
- NCT06040853
- Acronym / sponsor ID
- traneksamicanalgesia
- Conditions
- Pharmacological Action
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic group | Experimental | Drug: Tranexamic acid intravenous administrationAfter 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 | Placebo comparator | Drug: SalineThe control group will be given intravenous 100 ml of saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Coagulation disorder,
- Chronic renal failure,
- Patients allergic to tranexamic acid,
- Participant Age<18
- Participant Age>75,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid intravenous administrationAlso: intravenous saline administrationParticipants 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 | tranexamic group |
| SalineAlso: intravenous saline administrationParticipant was given intravenous 100 ml saline | Drug | placebo group |
Primary outcome
Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic,
Time frame: 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,
1 secondary outcome
side effect, 0., 1., 6. hours hemogram value, amount of antiemetic used
Time frame: Change from baseline at 0., 1., 6. hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 40358732Arslan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülten Arslan study director
DrLutfiKirdar training and research hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid intravenous administration and Saline in people with Pharmacological Action, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gülten arslan, Assoc prof (+905323620366 ext. 2176, gulten.arslan@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale, time of first analgesic requirement, used within 24 hours amount of analgesic, (time frame: Change from baseline at 0., 6., 12., 24., 48., 72. hours VAS score). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.