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IRCT20250630066304N5 IRCT 2026-06-16 Mazandaran University of Medical Sciences Effect of preoperative oral Alprazolam on pain intensity after lumbar disc surgery Effect of preoperative oral Alprazolam on pain intensity after lumbar disc surgery 2026-06-22 anticipated 42 Recruiting https://irct.ir/trial/85686 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Block randomization with a block size of 4 was used. The random allocation sequence was generated by an independent person using Random Allocation software. Allocation concealment was ensured through the use of sequentially numbered, sealed, opaque envelopes. The drug codes remained concealed until the end of statistical analysis. equally into two groups, Blinding description: To reduce bias, this study is designed as a double-blind study, meaning that: 1. Patients will not be aware of their treatment group. 2. Doctors and medical staff responsible for assessing pain severity and recording side effects will also be unaware of the assigned group. 3. The medications will be provided and numbered in identical, unmarked packages of the same color and size by someone outside the research team. 3 En Postoperative pain. Intervention 1: Intervention group: Intervention group: Oral alprazolam0.5mg (manufactured by Actoverco Company). Patients received a single 0.5mg 1hours before surgery. Intervention 2: Control group: Control group: Placebo tablet (produced by Sari School of Pharmacy, composed of starch, identical in size, shape, and color to alprazolam). Patients received one tablet 1 hours before 1hours before surgery, identical to the intervention group schedule. Yes - There is a plan to make this available What will be shared: Shared documents and data: Individual Participant Data (IPD): De-identified data of 75 patients in three groups (placebo,alprazolam 0.5mg, ) including age, weight, fasting blood glucose, surgery duration, pain intensity by VAS at 8 time points (0,30min,4,24h), fentanyl consumption within 24h, PONV incidence, time to first analgesic. Study Protocol: Full protocol in Persian and English (introduction, objectives, methodology, criteria, randomization, blinding, intervention, outcomes, sample size, statistical analysis). Statistical Analysis Plan (SAP): Complete analysis plan with SPSS 24, tests (Shapiro-Wilk, chi-square, ANOVA, repeated measures ANOVA, GEE), significance level 0.05. Informed Consent Form: Patient-signed form without personal identifiers. Clinical Study Report (CSR): Final report including full results, tables, figures, subgroup analyses. Data Dictionary: Definition of all variables, types, ranges, coding, and units. When: Six months after final publication of study results in a peer-reviewed journal (access start date: six months after article acceptance). Access will remain available for five years from that date. To whom: Researchers affiliated with reputable academic or research institutions (domestic or international) who have ethics committee approval for a research proposal related to postoperative pain management or meta-analysis. Industry-affiliated individuals may be allowed only with explicit permission from the principal investigator and a commitment to non-commercial use. Conditions: Data and documents may be used solely for academic research purposes (including meta-analysis, re-analysis, secondary studies related to postoperative pain or its complications). Commercial or for-profit use is strictly prohibited. Any publication derived from these data must cite the original clinical trial as the source. Requests must include a one-to-three-page research proposal specifying objectives, analysis methods, and expected outputs, along with ethics committee approval from the applicant's institution. The applicant must sign a confidentiality and non-commercial use agreement. Where to obtain: Requests should first be sent to the Principal Investigator (corresponding author) via email: (Aliehzamani@gmail.com). If no response within four weeks, requests may be directed to the Vice-Chancellor for Research and Technology, Mazandaran University of Medical Sciences at: Moallem Square, Building No. 2, Third Floor, Sari, Iran, Postal code 33971-48157, Tel +98 33044001, Email pajhoheshi@mazums.ac.ir. Mailing address: pajhoheshi@mazums.ac.ir. How to obtain: Applicant submits written request including research proposal and ethics approval to PI's email. Request reviewed by PI and a selected research team member within two weeks (scientific and ethical evaluation). If approved, applicant signs confidentiality and non-commercial use agreement. Data (encrypted SPSS or Excel file) and requested documents sent via secure cloud link or encrypted email. Entire process from request receipt to data delivery takes a maximum of four weeks. If denied, written explanation is provided. Comments: All shared data will be devoid of patient identifiers (name, surname, medical record number, national ID, phone number). Access to raw data is subject to compliance with data protection and confidentiality laws of the Islamic Republic of Iran and international standards (e.g., GDPR for international collaborators). Researchers from outside Iran must also sign a data protection compliance agreement. No custom analysis scripts/codes exist because all analyses were performed using SPSS software with graphical user interface.
public Dr.Samira Sobhani
Razi Street
Sari Iran (Islamic Republic of) 4816633131 +98 11 3311 1991 Ssobhani1983@gmail.com Mazandaran University of Medical Sciences scientific Dr.Samira Sobhani
Moallem Square, Building No. 2, Third Floor, Vice-Chancellor for Research and Technology, Mazandaran University of Medical Sciences, Sari, Iran
Sari Iran (Islamic Republic of) 4816633131 0098 11 3304401 Ssobhani1983@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Confirmation of diagnosis through physical examination, CT scan, and MRI Patient’s willingness to participate in the study and provision of informed consent. Candidate for non-emergency discectomy surgery. Age between 35 and 70 years. No history of hypersensitivity to benzodiazepines. 35 years 70 years Both Patient’s withdrawal of consent to continue participation at any time. Emergency discectomy surgery. Presence of more than two lumbar disc involvements. Use of opioid analgesics within 12 hours prior to the intervention. History of alcohol or substance abuse. Occurrence of any unusual intraoperative complications. Known hypersensitivity to benzodiazepines. 8. Patients with contraindications to alprazolam, including severe respiratory failure, pregnancy and lactation, or history of addiction and substance abuse. Prevention Placebo Intervention group: Intervention group: Oral alprazolam0.5mg (manufactured by Actoverco Company). Patients received a single 0.5mg 1hours before surgery Control group: Control group: Placebo tablet (produced by Sari School of Pharmacy, composed of starch, identical in size, shape, and color to alprazolam). Patients received one tablet 1 hours before 1hours before surgery, identical to the intervention group schedule. Intensity of postoperative pain after lumbar disc surgery. Timepoint: Immediately upon arrival in recovery (time zero) and then 4 hours and 24 hours after surgery. Method of measurement: Visual Analogue Scale from zero to one hundred millimeters where zero means no pain and one hundred means the worst imaginable pain. Total amount of opioid analgesic (fentanyl) consumed during the first twenty four hours after surgery. Timepoint: Twenty four hours after surgery (cumulative consumption is measured). Method of measurement: Recording the total dose of fentanyl consumed (in milligrams) from the patient's medical record. (Postoperative Nausea and Vomiting) Occurrence of nausea or vomiting after surgery (Postoperative Nausea and Vomiting). Timepoint: First twenty four hours after surgery. Method of measurement: Recording any episode of nausea or vomiting lasting more than five minutes using an adverse event checklist. Time interval between the end of surgery and the patient's first request for analgesic medication. Timepoint: At the time of occurrence (continuous measurement during the first twenty four hours after surgery). Method of measurement: Recording the exact time (in minutes) of the patient's first request for analgesic medication after surgery. Mazandaran University of Medical Sciences Approved 2024-11-11 Imam Khomeini Educational and Therapeutic Hospital, Sari – Mazandaran University of Medical Sciences Central Headquarters of Mazandaran University of Medical Sciences and Health Services, Beginning of Valiasr Highway, Juybar Junction, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)