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IRCT20200205046388N1 IRCT 2020-11-16 Oroumia University of Medical Sciences Evaluation of oral pregabalin administration on pain of patients undergoing prostate biopsy Evaluation of oral pregabalin and local anesthesia simultaneous administration effect on pain of patients undergoing prostate biopsy refered to imam hospital of Urmia 2020-11-10 anticipated 52 Complete https://irct.ir/trial/45812 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is based on blocks stratification and triple blind clinical trial, any patients will received any placebo or pregabalin cap. randomly. after determination of patients number (52 patients), according to epidemiological methods ,they stratified to A or B randomly and will receive placibo or pregabalin cap. according seal up pockets specified A or B, Blinding description: Because of placebo and drugs similarity, not only the participants but also the primary nurse prescribe the drugs, will not informed of basic trial and then the nurse who will collect data will not be known kind of prescribed capsule. 3 Prostate cancer. Intervention 1: Intervention group: single dose of PREGABALIN SOBHAN DAROU (Iran), 100MG CAP will prescribe in patients which be under routine TRUS biopsy prostate with Lidocaine local anesthesia, one hour before than biopsy. Intervention 2: Control group: patients underwent prostate biopsy with routine Lidocaine local anesthesia and receive placebo with no further intervention and with similar procedure of prostate biopsy. Yes - There is a plan to make this available What will be shared: Clinical and demographic findings after personal data deletion. When: one year after publish To whom: urologist in research or clinical fields Conditions: for repeating of research or experimental use of data Where to obtain: urology ward- Imam hospital in Urmia How to obtain: Direct request from researcher by web based connection Comments:
public Tayyebi Azar Ali
Ershad blvd., Imam Khomeini hospital
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3198 8749 ali.tyazar@gmail.com Oroumia University of Medical Sciences scientific Tayyebi Azar Ali
Ershad blvd., Imam Khomeini hospital
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3198 8748 ali.tyazar@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Male patients with PSA ≥4.0 ng/mL Lithotomy position for prostate biopsy is possible for participants 20 years no limit Male Prior pelvic pain before prostate biopsy TURP history Hormonal therapy or radiotherapy history Existing any Ano-rectal pathology C61 Malignant neoplasm of prostate Treatment - Drugs Placebo Intervention group: single dose of PREGABALIN SOBHAN DAROU (Iran), 100MG CAP will prescribe in patients which be under routine TRUS biopsy prostate with Lidocaine local anesthesia, one hour before than biopsy. Control group: patients underwent prostate biopsy with routine Lidocaine local anesthesia and receive placebo with no further intervention and with similar procedure of prostate biopsy Pain after prostate biopsy. Timepoint: 1 and 6 hours after biopsy. Method of measurement: Pain Analogue Questionnaire. Oroumia University of Medical Sciences Approved 2020-01-29 Ethics committee of Urmia University of Medical Sciences Vice chancellor for resaerch, Central building of UMSU. Resalat Avn. Urmia West Azarbaijan Iran (Islamic Republic of)