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IRCT20260216068880N1 IRCT 2026-03-31 Karaj University of Medical Sciences Effect of Intraperitoneal Dexmedetomidine on Postoperative Pain after Cesarean Section Comparison of the Effect of Intraperitoneal Dexmedetomidine and Normal Saline on Postoperative Pain Severity after Elective Cesarean Section in Pregnant Women 2026-04-04 anticipated 60 Complete https://irct.ir/trial/89221 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a randomized, double-blind, parallel-group clinical trial conducted as a pilot study, Randomization description: Participants will be randomly allocated into two groups using a computer-generated random sequence Randomization will be performed at the individual level using simple randomization Allocation concealment will be ensured using sequentially numbered, sealed opaque envelopes A researcher not involved in patient care or outcome assessment will generate the random sequence and prepare the envelopes, Blinding description: This study will be conducted as a double-blind randomized clinical trial Participants, clinical care providers, investigators, and outcome assessors will be blinded to group allocation Study medications will be prepared by an anesthesiologist not involved in patient care or outcome assessment and labeled with coded identifiers Both dexmedetomidine and normal saline will be prepared in identical syringes with the same volume and appearance Group allocation codes will be concealed until completion of data analysis. 3 Postoperative pain after cesarean section. Intervention 1: Intervention group: Dexmedetomidine, manufactured by Shahid Ghazi Pharmaceutical Company (Tabriz, Iran), administered intraperitoneally at a dose of 1 µg/kg, diluted in 40 mL of normal saline, and given at the end of surgery after uterine closure. Intervention 2: Control group: Intraperitoneal administration of 40 milliliters normal saline (Shahid Ghazi Pharmaceutical Company, Tabriz, Iran) at the end of surgery after uterine closure. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data including demographic characteristics, clinical variables, and outcome measures; study protocol; statistical analysis plan; informed consent form; clinical study report; analysis codes; and data dictionary When: Data will be available starting 6 months after publication of the study results and will remain accessible for up to 5 years To whom: Researchers affiliated with academic or research institutions upon reasonable request Conditions: Data will be shared for scientific research purposes with a methodologically sound proposal and after approval by the principal investigator; data use agreement is required Where to obtain: Requests should be sent to the principal investigator via email at moradi.fatemeh2020@gmail.com How to obtain: Requests will be reviewed within 2 weeks and eligible applicants will receive access within 1 month after approval Comments: All shared data will be fully deidentified to ensure participant confidentiality
public Fatemeh Moradi
Alley 7, North Khayyam Street, Marvdasht, Fars, Iran
Marvdasht Iran (Islamic Republic of) 7371451964 +98 71 4331 5233 moradifatemeh2020@gmail.com Karaj University of Medical Sciences scientific Fatemeh Moradi
Alley 7, North Khayyam Street, Marvdasht, Fars, Iran
Marvdasht Iran (Islamic Republic of) 737145964 +98 71 4331 5233 moradifatemeh2020@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 40 years Undergoing elective cesarean section under spinal anesthesia ASA physical status II Second cesarean delivery Ability to understand and report pain using Visual Analog Scale Provision of written informed consent 18 years 40 years Female Emergency cesarean section Preterm pregnancy Age below 18 or above 40 years History of allergy to dexmedetomidine Underlying systemic diseases Use of analgesics or sedatives within 24 hours before surgery Refusal to participate O82 Encounter for cesarean delivery without indication Treatment - Drugs Treatment - Drugs Intervention group: Dexmedetomidine, manufactured by Shahid Ghazi Pharmaceutical Company (Tabriz, Iran), administered intraperitoneally at a dose of 1 µg/kg, diluted in 40 mL of normal saline, and given at the end of surgery after uterine closure Control group: Intraperitoneal administration of 40 milliliters normal saline (Shahid Ghazi Pharmaceutical Company, Tabriz, Iran) at the end of surgery after uterine closure Postoperative pain severity after cesarean section. Timepoint: Immediately after recovery and every 15 minutes up to 3 hours after surgery. Method of measurement: Visual Analogue Scale for pain assessment. Postoperative opioid consumption. Timepoint: During recovery period up to 3 hours after surgery. Method of measurement: Total dose of administered pethidine recorded in milligrams. Postoperative blood pressure. Timepoint: Before intervention and every 15 minutes up to 3 hours after surgery. Method of measurement: Measured using a standard calibrated blood pressure monitoring device. Arterial oxygen saturation. Timepoint: Before intervention and every 15 minutes up to 3 hours after surgery. Method of measurement: Measured using a standard pulse oximeter. Postoperative nausea and vomiting. Timepoint: During recovery period up to 3 hours after surgery. Method of measurement: Clinical assessment based on presence or absence of nausea and vomiting. Postoperative shivering. Timepoint: During recovery period up to 3 hours after surgery. Method of measurement: Clinical assessment based on presence or absence of shivering. Karaj University of Medical Sciences Approved 2025-05-26 Ethics Committee of Alborz University of Medical Sciences Alborz University of Medical Sciences, Taleghani Boulevard, Taleghani Square, Karaj, Iran Karaj Alborz Iran (Islamic Republic of)