NCT06701929 | NOT YET RECRUITING | Quality Improvement

Detailed Description:

Study Design: This will be a prospective observational study. Patients will be approached by a member of the care team to ask if they are interested in speaking with the research coordinator. If they agree, the research coordinator will explain the study and provide informed consent. Patients agreeing to participate will be approached approximately 24 hours after surgery to conduct the eleven-question survey. The questions listed in the survey are listed in Appendix 1 (English version), and Appendix 2 (French version). Inclusion Criteria: All patients presenting to the Jewish General Hospital for elective cesarean section under spinal anesthesia will be considered for inclusion. Exclusion Criteria: Patients who are unable to communicate in French or English will be excluded. Patients presenting for urgent cesarean section will be excluded as well, as will those with a planned general anesthetic. Blinding: Blinding will not be present in this study. Baseline Data: Baseline data collected on patients will include patient age, number of previous pregnancies, number of previous deliveries, number of previous cesarean sections, body mass index, and any co-morbid diseases. The time that the patient last ate and last drank will be ascertained as well. Intraoperative data collected will include the time of spinal anesthesia, the time of the start and the end of the surgery, the dose of spinal anesthesia, the dose of intrathecal narcotics, the presence of a vasopressor infusion, the volume of fluid administered intraoperatively, and the use of parenteral analgesics. Baseline surgical data will include whether the peritoneum was closed, and which uterotonic medications were administered, as well as the dose. Outcomes: Primary Outcome: The primary outcome will be the ObsQoR-11 score approximately 24 hours after surgery. Secondary Outcomes: Secondary outcomes will include the presence of nausea, vomiting or retching during surgery, the volume of intravenous fluid administered, the dose of vasopressor administered, the pain scores two hours after surgery, and the dose of opioid used in the 24 hours after surgery. The estimated blood loss will be tracked as well. Statistical Analysis: The primary analysis will be a linear regression to determine if there is a statistically significant correlation between fasting time and the ObsQoR-11 score while factoring in the above-mentioned variables. Secondary analyses will be conducted to determine if the fasting duration correlates with a change in any of the eleven components of the ObsQoR-11 score or the secondary outcomes listed. In addition, the fasting data will be plotted against the ObsQoR-11 score to determine if an inflection point is present. Sample Size Calculations: There will be ten independent variables included in the regression (time since last meal, time since last drink, age, BMI, surgery duration, dose of spinal anesthesia, dose of intraoperative narcotics, presence of a vasopressor infusion, uterotonic medications, and peritoneal closure). We will aim to have ten observations for each independent variable, for a total of 100 patients in the study.