Studying the effect of intravenous lidocaine on reducing shivering after spinal anesthesia in cesarean section patients referred to Imam Khomeini Hospital in Sari A double-blind clinical trial

To investigate the effect of intravenous lidocaine on the severity of post-spinal anesthesia shivering in patients undergoing cesarean section.

A randomized, double-blind, placebo-controlled clinical trial with two parallel groups.

The study will be conducted at Imam Khomeini Hospital, Sari, Iran. Patients will undergo cesarean section under spinal anesthesia, and the assigned study solution will be administered following successful delivery of the neonate. Shivering severity, hemodynamic parameters, sedation level, body temperature, and nausea and vomiting will be assessed at 15, 30, 60, and 90 minutes.

patients undergoing cesarean section under spinal anesthesia, aged 18–65 years and classified as ASA physical status I–II, will be enrolled after providing written informed consent and meeting the eligibility criteria. Patients meeting any exclusion criteria will not be included.

Intervention group: Intravenous lidocaine at 1 mg/kg body weight. Control group: An equivalent volume of placebo (normal saline).

The primary outcome is the severity of post-spinal anesthesia shivering, assessed using a four-point scale at 15, 30, 60, and 90 minutes. Secondary outcomes include hemodynamic changes, body temperature, sedation level, and the incidence of nausea and vomiting.

A computer-generated randomization sequence is going to be prepared using IBM SPSS Statistics to allocate participants to the two study groups.

The study solutions will be prepared in identical volumes and coded to conceal treatment allocation. Participants and outcome assessors will remain unaware of group assignments. The severity of post-spinal shivering and other study outcomes will be assessed at the prespecified time points. Group codes will remain concealed until data collection and statistical analysis are completed. If emergency unblinding is required for patient safety, it will be performed according to the study protocol.

Individual participant data, including demographic and clinical characteristics, post-spinal anesthesia shivering severity, hemodynamic parameters, body temperature, sedation level, and the incidence of nausea and vomiting in patients undergoing cesarean section. Data will be stored confidentially using coded identifiers.

Data will be made available upon reasonable request after completion of the study and publication of the main results, subject to ethical and confidentiality requirements. The availability period will follow the university’s research data retention policies.

Qualified researchers and members of the scientific community with a valid research request may request access to the data, subject to participant confidentiality requirements.

Data may be used only for valid scientific and research purposes in accordance with research ethics principles. Use is subject to approval of the request, protection of participant confidentiality, and a prohibition on attempts to re-identify participants.

The data may be requested from the principal investigator or research team at Imam Khomeini Hospital, Sari, Iran.

A written request should describe the research objectives, proposed use of the data, and measures to protect confidentiality. The request will be reviewed by the principal investigator and, where necessary, the relevant research or ethics authorities. Access will be granted only after approval and agreement to comply with confidentiality requirements.