Efficacy And Safety of Prophylactic Rectal Diclofenac in Preventing Post-Anesthesia Shivering During Cesarean Section: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Determination of the effect of rectal diclofenac suppository prophylaxis on shivering after cesarean section

Study Design: Double-blind randomized controlled trial Two parallel groups (intervention vs placebo) Single-center study Sample Size: 100 total participants (50 per group) Calculated based on: Type I error (α) = 0.05 Power = 80% Expected minimum difference of 25% in post-anesthesia shivering between groups Randomization: Simple randomization method Individual-level randomization (not cluster) Computer-generated random numbers Double-blinding implemented (both patients and post-operative observers are blinded to group allocation) Study Groups: Intervention Group: Receives 100mg rectal diclofenac suppository 10 minutes before surgery Standard anesthesia protocol Control Group: Receives placebo suppository 10 minutes before surgery Same standard anesthesia protocol

This double-blind randomized controlled trial will be conducted at a single center. The study will involve women aged 18-40 years undergoing cesarean section with ASA status I or II. The operating room temperature will be maintained at 22-24°C throughout the procedures.

Inclusion Criteria: Women aged 18-40 years Undergoing cesarean section ASA status I or II Willing to participate in the study Exclusion Criteria: Allergy to diclofenac Cardiovascular disease Hypertension Diabetes Kidney disease Chronic lung disease Liver disease History of alcohol consumption Body temperature below 36°C Body temperature above 38°C

Receives 100mg rectal diclofenac suppository 10 minutes before surgery

Determination of the effect of rectal diclofenac suppository prophylaxis on shivering after cesarean section

This research is structured as a double-blind randomized controlled trial utilizing simple randomization with computer-generated random numbers. The randomization occurs at the individual patient level, where eligible participants (women aged 18-40 years undergoing cesarean section with ASA status I or II) are randomly allocated into one of two study arms. The intervention group receives a 100mg rectal diclofenac suppository 10 minutes prior to surgery, while the control group receives a placebo suppository. To maintain the integrity of the double-blind design, both the patients and the post-operative ward observers are kept unaware of group assignments.

This clinical trial employs a double-blind design with multiple levels of blinding to ensure the validity of results. The blinding process encompasses both the study participants and the healthcare providers involved in post-operative care. The study maintains blinding through the use of identical-appearing suppositories for both the active drug (100mg diclofenac) and placebo groups.

The study will share de-identified individual participant data (IPD) including demographic information, clinical measurements, and treatment outcomes through a secure clinical trial data repository within 12 months after study completion. Access will be granted to qualified researchers who submit methodologically sound proposals and sign a data use agreement. Essential study documentation including the protocol, statistical analysis plan, informed consent form, and clinical study report will be made available through an institutional repository with DOI assignment within 6 months of study completion. The primary manuscript and supplementary materials will be published in a peer-reviewed journal, with results also posted to the clinical trial registry within 12 months of completion. Raw data including de-identified datasets, data dictionary, and codebook will be shared through a secure repository upon reasonable request after publication.

The primary manuscript and supplementary materials will be published in a peer-reviewed journal, with results also posted to the clinical trial registry within 12 months of completion.

Access will be granted to qualified researchers who submit methodologically sound proposals and sign a data use agreement.

Access to study data and documents will be granted to qualified researchers affiliated with academic or research institutions who submit a methodologically sound research proposal. All requests will undergo review by a designated committee including principal investigators and institutional representatives within 4-6 weeks. The evaluation will consider the scientific validity, researcher qualifications, potential public health benefit, and feasibility of the proposed analysis. Approved users must sign a data use agreement specifying that data can only be used for the approved research purpose, no re-identification of participants will be attempted, proper citation of the original study is required, and results from secondary analyses must be shared with the original research team. The data must be stored securely with access limited to approved team members, and proper data destruction is required after project completion. Data will be available within 12 months of study completion, with access duration limited to the approved project timeline.

The data and documents will be available through direct contact with the principal investigator, Dr. Leila Nazari, who will serve as the primary point of contact for data sharing requests. Here are the specific contact details and procedures: Contact Information: • Primary Contact: Dr. Leila Nazari (Principal Investigator) • Department: Obstetrics and Gynecology • Institution: Shahid Beheshti University of Medical Sciences • Email: nazari@sbmu.ac.ir Access Procedures: 1. Interested researchers should submit their data access requests via email to the principal investigator 2. The request should include: o A brief research proposal o Intended use of the data o Researcher credentials o Institutional affiliation o Timeline for data use The principal investigator will review requests within 4-6 weeks and provide access to approved researchers through secure file sharing platforms or institutional repositories.

The request should include: o A brief research proposal o Intended use of the data o Researcher credentials o Institutional affiliation o Timeline for data use The principal investigator will review requests within 4-6 weeks and provide access to approved researchers through secure file sharing platforms or institutional repositories.