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IRCT20141009019470N108 IRCT 2021-02-06 Shiraz University of Medical Sciences The effect of prostatic regional block on post-operative urethral catheter discomfort in transurethral prostatectomy surgery The effect of prostatic regional block on post-operative urethral catheter discomfort in transurethral prostatectomy surgery 2021-02-20 anticipated 42 Complete https://irct.ir/trial/53851 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using a random table taken from sealedenvelped.com and 4 and 6 permutation blocks patients are divided into two groups .Patients were placed in the intervention or control group upon entering the operating room, Blinding description: The surgeon and the person preparing the medicine and providing it to the surgeon were aware of the type of study; While the patient, the patient evaluator in the recovery room and the statistical analyst were unaware of the type of study and block performed. 2-3 Benign prostatic hyperplasia. Intervention 1: Intervention group: Patients in the first group will received with 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery. Intervention 2: Control group: Patients will not received with 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is Its against our policies.
public Fatane Jamshidi
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 fatanejamshidi@gmail.com Shiraz University of Medical Sciences scientific Ali Karami
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 alk1380@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 50-70 years ASA one and two patients undergoing prostate surgery patients under general anesthesia 50 years 70 years Male Uncontrolled underlying disease History of chronic pelvic pain Opium addicts Anxiety disorders Restlessness Time and space loss Confusion Tremor Shivering Seizures, tinnitus Bradycardia Decreased cardiac function Hypotension Cardiovascular collapse Respiratory arrest Nausea and vomiting Cases in which the surgeon decides to perform open prostatectomy for any reason, including active bleeding History of discopathy History of coagulopathy D29.1 Benign neoplasm of prostate Prevention N/A Intervention group: Patients in the first group will received with 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery. Control group: Patients will not received with 0.5 mg / kg bupivacaine during one minute for periprostatic block by transrectal method at the end of the surgery. Post-operative urethral catheter discomfort. Timepoint: At the beginning of the recovery and then 30, 60, 90 and 120 minutes later and at the time of transfer to the ward. Method of measurement: During the two hours of patients' stay in recovery, the amount of pain and discomfort caused by the urethral catheter is divided into three degrees: Zero: Do not feel discomfort caused by the catheter. One: Patients feel mild discomfort after the question but do not complain on their own. Two: Patients without question express a feeling of urination, discomfort in the suprapubic or burning urination. Three: Feeling uncomfortable with unquestioning behaviors such as kicking the bed, yelling at the nurse, trying to remove the urethral catheter. Morphine consumption in recovery. Timepoint: Time of discharge from recovery. Method of measurement: observation. Blood pressure. Timepoint: During the operation and after the operation until the transfer to the recovery and in recovery every 15 minutes. Method of measurement: Monitoring. Recovery Stay. Timepoint: Duration of presence in recovery. Method of measurement: When Aldrete score time reaches 6. Shiraz University of Medical Sciences Approved 2016-06-17 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)