Comparison of the Effect of Intraperitoneal Dexmedetomidine and Normal Saline on Postoperative Pain Severity after Elective Cesarean Section in Pregnant Women

To evaluate the effect of intraperitoneal dexmedetomidine on postoperative pain severity after elective cesarean section

Randomized, double blind, parallel group phase 3 clinical trial with 60 participants using computer generated randomization and allocation concealment

The present study is conducted at Kamali Hospital in Karaj on pregnant women who are candidates for elective cesarean section. All patients receive standard spinal anesthesia, and complete monitoring of vital signs is performed throughout the surgery. In the intervention group, dexmedetomidine at a dose of 1 µg/kg, diluted in 40 mL of normal saline, is administered intraperitoneally at the end of surgery after uterine closure. In the control group, 40 mL of normal saline is administered in the same manner. The study drugs are prepared in identical syringes by an independent anesthesiologist, and participants, clinical staff, and outcome assessors are blinded to group allocation (double-blind). Postoperatively, pain severity is assessed at predefined time intervals, and analgesic consumption, vital signs, and potential adverse effects are recorded and compared.

Inclusion criteria: Women aged 18 to 40 years undergoing elective cesarean section under spinal anesthesia with ASA class II and second cesarean delivery; exclusion criteria include emergency cesarean section, preterm pregnancy, underlying systemic disease, allergy to dexmedetomidine, use of analgesics or sedatives within 24 hours before surgery, and refusal to participate

Intervention group receives intraperitoneal dexmedetomidine at a dose of 1 microgram per kilogram diluted in 40 milliliters normal saline; control group receives 40 milliliters normal saline intraperitoneally

Postoperative pain severity based on Visual Analog Scale

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.

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.

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

Data will be available starting 6 months after publication of the study results and will remain accessible for up to 5 years

Researchers affiliated with academic or research institutions upon reasonable request

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

Requests should be sent to the principal investigator via email at moradi.fatemeh2020@gmail.com

Requests will be reviewed within 2 weeks and eligible applicants will receive access within 1 month after approval

All shared data will be fully deidentified to ensure participant confidentiality