JRCT ID: jRCTs061250096
Registered date:02/03/2026
Study of Pain Relief Using Diclofenac Patches after Robot-Assisted Prostate Cancer Surgery
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Postoperative Pain after Robot-Assisted Radical Prostatectomy |
| Date of first enrollment | 02/03/2026 |
| Target sample size | 40 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | On the day before surgery, apply two transdermal diclofenac sodium patches (each containing 75 mg of diclofenac sodium) to the back. After completion of the surgery, replace them with new patches of the same medication and continue application until the day after surgery. |
Outcome(s)
| Primary Outcome | VAS score at postoperative day 1 (24 hours after surgery) |
|---|---|
| Secondary Outcome | VAS score immediately after surgery Use of additional analgesics Presence or absence of bladder tenesmus due to urethral catheter after surgery |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male |
| Include criteria | 1. Patients after robot-assisted radical prostatectomy for prostate cancer 2. Patients aged 18 years or older at the time of obtaining informed consent 3. Patients who are able to provide written informed consent for participation in this study |
| Exclude criteria | 1. Patients with active peptic ulcer 2. Patients with hematological disorders (aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenia) 3. Patients with severe renal impairment 4. Patients with severe hepatic dysfunction 5. Patients with severe hypertension 6. Patients with congestive heart failure 7. Patients with a history of hypersensitivity to diclofenac sodium 8. Patients with aspirin-induced asthma or a history thereof 9. Patients receiving triamterene 10. Patients with acute or chronic pain due to underlying disease prior to surgery 11. Patients scheduled to receive PCEA, IV-PCA, or continuous nerve block anesthesia after surgery 12. Patients who routinely use opioid analgesics (regardless of the route of administration) or transdermal formulations of other analgesics 13. Patients with severe psychiatric disorders 14. Patients with a history of alcohol or drug abuse 15. Patients who are currently participating in another clinical study or intend to participate during this study 16. Patients judged by the principal investigator or sub-investigator to be clearly disadvantaged by participation in this study 17. Patients judged by the principal investigator or sub-investigator to make the conduct or evaluation of this study difficult by participation 18. The principal investigator or sub-investigator of this study, their family members, or employees of the participating institution |
Related Information
| Primary Sponsor | Tsutsumi Yasuo |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yasuo Tsutsumi |
| Address | 1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, Japan Hiroshima Japan 734-8551 |
| Telephone | +81-82-257-5267 |
| masuika@hiroshima-u.ac.jp | |
| Affiliation | Hiroshima university Hospital |
| Scientific contact | |
| Name | Yasuo Tsutsumi |
| Address | 1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima, Japan Hiroshima Japan 734-8551 |
| Telephone | +81-82-257-5267 |
| masuika@hiroshima-u.ac.jp | |
| Affiliation | Hiroshima university Hospital |