Effect of preoperative oral Alprazolam on pain intensity after lumbar disc surgery

The effect of preoperative oral alprazolam on postoperative pain intensity following lumbar disc surgery.

This is a phase 3, randomized, double-blind, parallel-group, controlled clinical trial conducted on 42 patients. For randomization, the RAND function in Microsoft Excel software was utilized.

This randomized, double-blind, placebo-controlled trial at Imam Khomeini Hospital, Sari, evaluates preoperative oral alprazolam's effect on postoperative pain in elective discectomy patients. Via block randomization, Group A receives 0.5mg alprazolam and Group B receives a placebo one hour pre-surgery. Patients and outcome assessors are blinded. Following standardized general anesthesia, patients' pain, nausea, vomiting, and itching are evaluated before recovery discharge, and at four and 24 hours post-surgery.

IInclusion Criteria: Confirmed lumbar disc disease, informed consent, elective surgery, age 35–70, and no benzodiazepine hypersensitivity. Exclusion Criteria: Consent withdrawal, emergency surgery, more than two disc involvement, opioid use within 12 hours prior, intraoperative complications, benzodiazepine allergy, or alprazolam contraindications..

Group A receives one tablet of alprazolam 0.5 mg, and Group B receives a placebo, one hour prior to surgery

Postoperative pain intensity, The amount of postoperative opioid consumption.

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.

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.

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.

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.

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.

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.

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.

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.

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.