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IRCT20190325043107N84 IRCT 2026-08-13 Tabriz University of Medical Sciences The Effect of Dexamethasone on Shoulder Pain and Nausea After Hysterectomy Efficacy of Intraoperative Dexamethasone Infusion in Mitigating Shoulder Pain and Postoperative Nausea and Vomiting Following Laparoscopic Hysterectomy 2026-09-08 anticipated 130 Recruiting https://irct.ir/trial/92069 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, with a sample size of 130, participants will be assigned to three groups using permuted block randomization. A block size of four will be employed, utilizing all possible combinations, including: Block 1 (BBAA), Block 2 (AABB), Block 3 (ABAB), Block 4 (BABA), Block 5 (ABBA), and Block 6 (BAAB). To accommodate 130 participants, 33 blocks will be generated using Random Allocation Software, with blocks randomly selected from numbers 1 to 6. For instance, if block 6 and block 2 are selected sequentially, the allocation sequence will be BAABAABB, assigning individuals to Intervention Group (A), Intervention Group (B), and the Control Group, Blinding description: In this study, to ensure proper patient blinding, the medications for groups A and B will be prepared in identical appearance, color, packaging, and administration method, making them indistinguishable to participants. Each medication will be labeled with a unique code (A or B), known only to an independent researcher who is not involved in patient recruitment or evaluation. The envelopes containing the coded medication will be provided to the study investigator in sequential order, without any indication of treatment type. Consequently, both patients and the investigator will remain unaware of group allocation, thus maintaining a practical and effective double‑blind design throughout the trial. 2-3 Pain intensity. Intervention 1: Intervention group: Patients in the intervention group will receive an intravenous infusion of dexamethasone (0.2 mg/kg) over 10 minutes, starting 3 minutes after anesthesia induction. Shoulder pain will be assessed using the Visual Analog Scale (VAS), and postoperative nausea and vomiting will be evaluated and recorded at predefined postoperative time points. Intervention 2: Control group: Patients in the control group will receive an equal volume of normal saline as placebo by intravenous infusion over 10 minutes, starting 3 minutes after anesthesia induction. Shoulder pain will be assessed using the Visual Analog Scale (VAS), and postoperative nausea and vomiting will be evaluated and recorded at the same predefined postoperative 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 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 Iran (Islamic Republic of) Women aged 15 to 65 years Written informed consent for participation in the study 15 years 65 years Female Hypersensitivity reaction to dexamethasone Patients with a history of hypertension G89.11 Acute pain due to trauma Prevention Placebo Intervention group: Patients in the intervention group will receive an intravenous infusion of dexamethasone (0.2 mg/kg) over 10 minutes, starting 3 minutes after anesthesia induction. Shoulder pain will be assessed using the Visual Analog Scale (VAS), and postoperative nausea and vomiting will be evaluated and recorded at predefined postoperative time points. Control group: Patients in the control group will receive an equal volume of normal saline as placebo by intravenous infusion over 10 minutes, starting 3 minutes after anesthesia induction. Shoulder pain will be assessed using the Visual Analog Scale (VAS), and postoperative nausea and vomiting will be evaluated and recorded at the same predefined postoperative time points. Shoulder pain syndrome. Timepoint: Every 12 hours for three days. Method of measurement: Visual analog scale. Tabriz University of Medical Sciences Approved 2026-07-26 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)