]>

IRCT20240221061070N8 IRCT 2025-11-18 Esfahan University of Medical Sciences Effect of Meperidine and Dexmedetomidine on Post‑Cesarean Analgesia Comparative study of the preventive effect of intravenous meperidine and intravenous dexmedetomidine on analgesia after cesarean section 2025-11-22 anticipated 120 Complete https://irct.ir/trial/87139 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants are randomly assigned to one of three groups (meperidine, dexmedetomidine, or placebo) using block randomization (blocks of 15) generated through random.org. Allocation concealment is maintained through sealed opaque envelopes prepared by an independent statistician. The study is triple‑blind (investigator, participants, and outcome assessor), Blinding description: This clinical trial is conducted under a triple‑blind design to ensure unbiased assessment of outcomes. The study drugs (meperidine, dexmedetomidine, and normal saline) are prepared by an anesthesiologist not involved in data collection, using identical, coded syringes labeled A, B, and C. Only the anesthesiologist and the randomization coordinator know the allocation code until data analysis is completed. The principal investigator, participants, clinical caregivers, outcome assessor (VAS), and data analyst are all blinded to group assignment. At the end of the study, the randomization codes are disclosed by an independent statistician for final data analysis. Bioequivalence Post‑Cesarean Pain (Postoperative Pain after Cesarean Section). Intervention 1: Control group: 10 mL of intravenous normal saline. Intervention 2: Intervention group: 10 mg of intravenous meperidine (Meperidine HCl 10 mg/10 mL). Intervention 3: Intervention group: 10 µg of intravenous dexmedetomidine (Dexmedetomidine HCl 10 µg/10 mL). No - There is not a plan to make this available Justification or reason for not sharing IPD is The data is private

public Milad Masaeli

Apposite of Asman Hotel, The beginning of Shahid Motahari St., Felezzi Bridge, Isfahan

Esfahan Iran (Islamic Republic of) 8184853541 +98 31 3236 7001 drmilmas@gmail.com Esfahan University of Medical Sciences scientific Milad Masaeli

Apposite of Asman Hotel, The beginning of Shahid Motahari St., Felezzi Bridge, Isfahan

Esfahan Iran (Islamic Republic of) 8184853541 +98 31 3236 7001 drmilmas@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Pregnant women classified as ASA II Age range between 18 and 45 years Candidates for elective cesarean section under spinal anesthesia Written informed consent to participate in the study No known allergy to the study medications (meperidine or dexmedetomidine) 18 years 45 years Female Known cardiac, pulmonary, hepatic, or renal disease Psychiatric disorders, diabetes mellitus, or thyroid dysfunction Body temperature at operating room admission < 36.5 °C or > 37.5 °C History of alcohol or substance abuse Use of vasodilator medications Requirement of intraoperative blood transfusion G89.18 Other acute postprocedural pain Placebo Prevention Prevention Control group: 10 mL of intravenous normal saline Intervention group: 10 mg of intravenous meperidine (Meperidine HCl 10 mg/10 mL) Intervention group: 10 µg of intravenous dexmedetomidine (Dexmedetomidine HCl 10 µg/10 mL) Postoperative pain intensity after cesarean section. Timepoint: At baseline (0 hour), 2 hours, 4 hours, 6 hours, and 8 hours after surgery. Method of measurement: The primary variable (postoperative pain intensity) will be measured using the Visual Analogue Scale for pain assessment. This scale consists of a 10‑centimeter horizontal line with “no pain” marked at one end (score 0) and “the worst pain imaginable” at the other end (score 10). At each predefined postoperative time point (0, 2, 4, 6, and 8 hours after the cesarean section), the patient will indicate the intensity of pain by marking a point on the line corresponding to their perceived pain level. The score is obtained by measuring the distance in centimeters from the “no pain” anchor to the patient’s mark. Before surgery, all participants will be instructed on how to use the scale to ensure a consistent and valid understanding of pain rating across subjects. Esfahan University of Medical Sciences Approved 2025-10-05 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Al-Zahra Hospital, Daneshgah Street. Isfahan Isfehan Iran (Islamic Republic of)