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IRCT20190325043107N58 IRCT 2025-08-02 Tabriz University of Medical Sciences Comparison of the effect of adding dexmedetomidine, fentanyl, magnesium sulfate to bupivacaine Comparison of the effect of adding dexmedetomidine, fentanyl and magnesium sulfate to bupivacaine in the management of acute pain after knee replacement surgery. 2023-10-31 anticipated 120 Complete https://irct.ir/trial/84871 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study with a sample size of 120 participants, block permutation randomization will be used for allocation. Given that there are four study groups, participants are initially divided into two categories: groups A and B, with group A representing groups 1 (fentanyl) and 2 (dexmedetomidine), and group B representing groups 3 (magnesium sulfate) and 4 (control). Each block consists of four participants, with six possible arrangements: BBAA, AABB, ABAB, BABA, ABBA, and BAAB. The sequence of blocks will be determined randomly using the Random Allocation Software by selecting numbers from 1 to 6. For example, if block 6 (BAAB) and then block 2 (AABB) are selected, the allocation order for enrolled participants will be BAABAABB. In the second stage, each category (A and B) will be further randomized into its two subgroups, ensuring that each participant is ultimately assigned to one of the four main study groups. Thus, in this method, the letter A initially stands for groups 1 and 2, and B for groups 3 and 4; subsequently, members of each letter group are randomly allocated to one of their respective subgroups, resulting in a final allocation to one of the four study arms, Blinding description: The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of drug used, in this study they will not know what type of drug will be used in other patients.The injectable medications and placebo will be prepared in identical syringes of the same volume, shape, and color by the anesthesiologist. 2-3 Pain Intensity. Intervention 1: Intervention group 1: In Group 1, patients will receive 20 mg of bupivacaine solution combined with 25 micrograms of sterile fentanyl, and their postoperative pain intensity will be assessed at predetermined time points. Intervention 2: Intervention group 2: In Group 2, patients will receive 20 mg of bupivacaine solution combined with 25 micrograms of sterile dexmedetomidine, and their postoperative pain intensity will be assessed at predetermined time points. Intervention 3: Intervention group 3: In Group 3, patients will receive 20 mg of bupivacaine solution combined with 50 mg of magnesium sulfate, and their postoperative pain intensity will be assessed at predetermined time points. Intervention 4: Control group: In Group 4, patients will receive 20 mg of bupivacaine solution combined with 1 cc of normal saline, and their postoperative pain intensity will be assessed at predetermined time points. 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 There is no further information available.
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mahdi Nazari
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5165665631 +98 41 3335 7310 Mkhanbabayi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) ASA class I or II Scheduled for unilateral total knee arthroplasty Procedure performed by a single surgeon 18 years 70 years Both Contraindications to spinal anesthesia Patients with hypersensitivity to any of the study medications Patients with a blood pressure greater than 160 mmHg G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: In Group 1, patients will receive 20 mg of bupivacaine solution combined with 25 micrograms of sterile fentanyl, and their postoperative pain intensity will be assessed at predetermined time points. Intervention group 2: In Group 2, patients will receive 20 mg of bupivacaine solution combined with 25 micrograms of sterile dexmedetomidine, and their postoperative pain intensity will be assessed at predetermined time points. Intervention group 3: In Group 3, patients will receive 20 mg of bupivacaine solution combined with 50 mg of magnesium sulfate, and their postoperative pain intensity will be assessed at predetermined time points. Control group: In Group 4, patients will receive 20 mg of bupivacaine solution combined with 1 cc of normal saline, and their postoperative pain intensity will be assessed at predetermined time points. Pain Intensity. Timepoint: They will be measured at 1, 2, 4, 6, 12, 18, and 24 hours after surgery. Method of measurement: The Visual Analog Scale (VAS) was used to assess pain. Tabriz University of Medical Sciences Approved 2023-08-27 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)