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IRCT20190325043107N64 IRCT 2025-10-20 Tabriz University of Medical Sciences Preventive analgesia with methylprednisolone beta with and without gabapentin in elderly patients undergoing total knee arthroplasty The comparison of preventive analgesia with methylprednisolone plus gabapentin versus methylprednisolone alone in elderly patients undergoing total knee arthroplasty 2024-06-23 anticipated 140 Complete https://irct.ir/trial/86509 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, with a sample size of 140 participants, patients will be allocated into two groups using the block permutation randomization method. Each block will contain four patients, including all possible combinations: Block 1 – BBAA, Block 2 – AABB, Block 3 – ABAB, Block 4 – BABA, Block 5 – ABBA, and Block 6 – BAAB. For 140 participants, 35 blocks will be used, and block numbers from 1 to 6 will be randomly selected with the aid of Random Allocation Software. For example, if Block 6 is chosen as the first block and Block 2 as the second, the allocation sequence will be BAABAABB, assigning individuals to either the methylprednisolone plus gabapentin group (A) or the methylprednisolone without gabapentin group (B). To ensure allocation concealment, the randomization list will be prepared by an independent researcher who will not be involved in patient recruitment or assessment. The list will be numbered and sealed inside opaque, sequentially numbered, light‑impermeable envelopes. The principal investigator will open the envelopes in numerical order only after each participant has been enrolled and assigned a code, thereby preventing any prediction of group assignment, Blinding description: In this double-blind study, both patients and outcome assessors were kept unaware of group assignments by preparing the two medications in identical capsules with the same shape, size, color, and taste, manufactured and packaged by an independent pharmacist. Each capsule was labeled only with codes “A” and “B,” determined by a randomization table generated by an independent investigator. Thus, neither the patients, nor data analysts were informed of the assigned intervention, and the coding list remained confidential with the pharmacist until the completion of statistical analysis to ensure full blinding integrity. 2-3 Postoperative pain. Intervention 1: Intervention group 1: Thirty minutes before transfer to the operating room, patients will receive a 300‑mg oral gabapentin tablet with 50 mL of water, followed by intravenous administration of a 125‑mg methylprednisolone ampule. Pain intensity will be assessed using the Visual Analog Scale (VAS) over a 24‑hour period at two‑hour intervals. Intervention 2: Intervention group 2: Thirty minutes before transfer to the operating room, patients will receive an oral placebo tablet identical in color, size, and shape to the gabapentin tablet, along with 50 mL of water, followed by intravenous administration of a 125‑mg methylprednisolone ampule. Pain intensity will be assessed using the Visual Analog Scale (VAS) over a 24‑hour period at two‑hour intervals. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Avenue
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Avenue
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Over 60 years of age ASA class I or II Candidate for elective unilateral total knee arthroplasty 60 years 80 years Both Patients with any contraindication to spinal anesthesia Prior use of corticosteroid medications G89.11 Acute pain due to trauma Prevention Prevention Intervention group 1: Thirty minutes before transfer to the operating room, patients will receive a 300‑mg oral gabapentin tablet with 50 mL of water, followed by intravenous administration of a 125‑mg methylprednisolone ampule. Pain intensity will be assessed using the Visual Analog Scale (VAS) over a 24‑hour period at two‑hour intervals. Intervention group 2: Thirty minutes before transfer to the operating room, patients will receive an oral placebo tablet identical in color, size, and shape to the gabapentin tablet, along with 50 mL of water, followed by intravenous administration of a 125‑mg methylprednisolone ampule. Pain intensity will be assessed using the Visual Analog Scale (VAS) over a 24‑hour period at two‑hour intervals. Postoperative pain. Timepoint: Every two hours for 24 hours. Method of measurement: Visual Analog Scale (VAS). Tabriz University of Medical Sciences Approved 2024-06-23 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Avenue Tabriz East Azarbaijan Iran (Islamic Republic of)