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General information
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2023-12-06, 1402/09/15
2023-12-06 00:00:00
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2025-12-06, 1404/09/15
2025-12-06 00:00:00
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Updating the actual time of sampling and the realized sample size
Updating the actual time of sampling and the realized sample size
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به روزرسانی زمان بیمارگیری تحقق یافته و حجم نمونه تحقق یافته
به روزرسانی زمان بیمارگیری تحقق یافته و حجم نمونه تحقق یافته
Recruitment centers
#1
Name of recruitment center - English: Shohadaye Tajrish Hospital
Name of recruitment center - Persian: بیمارستان شهدای تجریش
Full name of responsible person - English: Hamidreza Azizi Farsani
Full name of responsible person - Persian: حمیدرضا عزیزی فارسانی
Street address - English: Quds Square, Shahrdari Street, Shohadaye Tajrish Hospital
Street address - Persian: میدان قدس، خ شهرداری، بیمارستان شهدای تجریش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 989934148
Phone: +98 21 25719
Fax: +98 21 2271 2241
Email: lib.shmc@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Shohadaye Tajrish Hospital
Name of recruitment center - Persian: بیمارستان شهدای تجریش
Full name of responsible person - English: Hamidreza Azizi Farsani
Full name of responsible person - Persian: حمیدرضا عزیزی فارسانی
Street address - English: Quds Square, Shahrdari Street, Shohadaye Tajrish Hospital
Street address - Persian: میدان قدس، خ شهرداری، بیمارستان شهدای تجریش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 989934148
Phone: +98 21 2271 8000
Fax: +98 21 2271 2241
Email: lib.shmc@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Shohadaye Tajrish Hospital Name of recruitment center - Persian: بیمارستان شهدای تجریش Full name of responsible person - English: Hamidreza Azizi Farsani Full name of responsible person - Persian: حمیدرضا عزیزی فارسانی Street address - English: Quds Square, Shahrdari Street, Shohadaye Tajrish Hospital Street address - Persian: میدان قدس، خ شهرداری، بیمارستان شهدای تجریش City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 989934148 Phone: +98 21 257192271 8000 Fax: +98 21 2271 2241 Email: lib.shmc@sbmu.ac.ir Web page address:
Protocol summary
Study aim
Investigating the effect of multimodal analgesia on the amount of perioperative narcotics consumption in urethral reconstruction surgery
Design
A clinical trial with 2 groups, with parallel groups, double blind, randomized, phase 3 on 30 patients. For randomization, a simple randomization method is used using a table of random numbers.
Settings and conduct
After the approval of the ethics committee and obtaining the consent of the patients, 30 candidates for urethral repair surgery of Shahada Tajrish Hospital who meet the entry criteria will be included in the study. Patients are assigned to one of the two groups by simple randomization. Individuals responsible for randomization from the research team will not be responsible for examining the dependent variable. The data analyst will not know about the coding of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who are candidates for urethral reconstruction treatment with normal mental status and adherence to the treatment plan, who have an ASA score I or II with normal lab tests.
Exclusion criteria:
Having an addiction to drugs or psychotropic substances
Intervention groups
The intervention group (M) is treated with gabapentin and clonidine drugs before surgery, and during surgery, patients are given dexamethasone, magnesium infusion, pudendal nerve block, and ropivacaine injection to remove buccal mucosa. Ketorolac and intravenous acetaminophen will be used at the end of the procedure. The control group (S) will only use the standard method of drug treatment with opioids and placebo tablets and solution will be used before and during the operation.
Main outcome variables
Perioperative opioid consumption
General information
Reason for update
Updating the actual time of sampling and the realized sample size
Acronym
IRCT registration information
IRCT registration number:IRCT20230204057318N3
Registration date:2023-11-20, 1402/08/29
Registration timing:prospective
Last update:2026-08-01, 1405/05/10
Update count:1
Registration date
2023-11-20, 1402/08/29
Registrant information
Name
Alireza Shakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 0000
Email address
dr.alirezashakeri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
2023-12-06, 1402/09/15
Actual recruitment end date
2025-12-06, 1404/09/15
Trial completion date
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Scientific title
Comparison of multimodal analgesia and opioid based method in urethral reconstruction surgery
Public title
Comparison of multimodal analgesia and opioid based method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient candidate for urethral reconstruction treatment
Mental health and providing informed consent
Ability to adhere to patient visit schedule and other relevant protocols
American Society of Anesthesiologist (ASA) score I or II
Normal kidney and liver function
Exclusion criteria:
Any condition that prevents obtaining informed consent.
Any other disease, including malignancy, abnormal laboratory tests, psychiatric disease, which in the opinion of the researcher prevents the patient from adhering to the study.
Concomitant or uncontrolled illness that, in the researcher's opinion, causes harm to the patient or non-adherence to the study.
History of drug addiction, psychoactive drugs and other illegal drug substances
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a simple randomization method was used using a table of random numbers and through the Random generator program of the Android version. In this randomization, patients who meet the criteria for entering the study are assigned a number before anesthesia, which will represent one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, the person responsible for data collection, and the data analyzer will be unaware of how the groups are coded. Only the anesthesiologist in charge of the patient will know about the patient group, but the attending physician will not.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Intervention group (M): One hour before patients enter the operating room, in group M, a dose of clonidine with a dose of 3 microgram/kg and a dose of gabapentin with a dose of 4 mg/kg will be given orally to the patients. Patients of both groups are put under general anesthesia in the same way. In group M, a dose of dexamethasone with a dose of 8 mg will be prescribed after the start of anesthesia. After the start of anesthesia and before the start of surgery for patients in group M, a bilateral pudendal nerve block will be performed with 10 ml of 0.5% ropivacaine under ultrasound guidance. During surgery for group M, magnesium sulfate infusion will be continued with an initial dose of 30mg/kg and then 15mg/kg/h until the end of the surgery. In order to remove the buccal graft, at the end of the work in group M, 0.25% bupivacaine solution with a volume of 10 mL will be used. At the end of the surgery in group M, a dose of intravenous ketorolac with a dose of 30 mg and a dose of intravenous paracetamol with a dose of one gram will be used.
Category
Treatment - Drugs
2
Description
Control group (S): One hour before the patients enter the operating room, two placebo tablets will be given to the patients orally in the S group. Patients of both groups are put under general anesthesia in the same way. In group S, 2 ml of normal saline (placebo) will be administered after the start of anesthesia. During surgery for group S, normal saline infusion will be used as a placebo until the end of surgery. To perform buccal graft removal, at the end of the work in group S, normal saline solution with a volume of 10 mL will be used. At the end of surgery in group S, morphine with a dose of 0.05mg/kg will be used intravenously.