Protocol summary
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Study aim
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Investigating the effect of multimodal analgesia on the amount of perioperative narcotics consumption in urethral reconstruction surgery
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Perioperative opioid consumption
General information
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Reason for update
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Updating the actual time of sampling and the realized sample size
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Acronym
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IRCT registration information
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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
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Registration date
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2023-11-20, 1402/08/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-22, 1402/09/01
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Expected recruitment end date
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2024-05-21, 1403/03/01
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Actual recruitment start date
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2023-12-06, 1402/09/15
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Actual recruitment end date
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2025-12-06, 1404/09/15
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Trial completion date
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empty
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Scientific title
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Comparison of multimodal analgesia and opioid based method in urethral reconstruction surgery
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Public title
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Comparison of multimodal analgesia and opioid based method
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-29, 1402/08/07
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1402.419
Health conditions studied
1
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Description of health condition studied
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Urethral reconstruction surgery
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ICD-10 code
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N35
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ICD-10 code description
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Urethral stricture
Primary outcomes
1
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Description
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Perioperative opioid consumption (intraop + postop)
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Timepoint
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intraoperative and postoperative
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Method of measurement
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Based on the amount of narcotics used and recorded in the patient's file
Secondary outcomes
1
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Description
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Intraoperative opioid consumption
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Timepoint
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Intraoperative
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Method of measurement
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Patient file information
2
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Description
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Postoperative opioid consumption
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Timepoint
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Postoperative up to 24h
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Method of measurement
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Patient file information
3
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Description
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Postoperative pain
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Timepoint
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Postoperative up to 24h
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Method of measurement
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VAS score
4
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Description
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Hospitalization days after surgery
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Timepoint
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Postoperative
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Method of measurement
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Hospitalization days
5
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Description
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Postoperative complications (nausea, vomiting, constipation)
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Timepoint
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Postoperative
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Method of measurement
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Observation/questionnaire
6
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Description
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Intraoperative hemodynamic (HR, MAP)
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Timepoint
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Intraoperative
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Method of measurement
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Hemodynamic monitoring
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available