Pilot Study Comparing Early General Anesthesia and Intravenous Sedation for Pain During Cesarean Section to Reduce Trauma

What this Trial Is About

The trial focuses on women undergoing cesarean delivery who experience severe pain during surgery despite standard neuraxial anesthesia methods like epidural or spinal anesthesia. It evaluates the feasibility of comparing two common approaches for managing this pain to help prevent post-traumatic stress disorder PTSD symptoms. The study is a pilot randomized trial involving patients who experience pain after the baby is delivered but that does not respond to first-line treatments. Participants will be randomly assigned to one of two groups early conversion to general anesthesia, which involves medically induced unconsciousness and a breathing tube, or a time-limited trial of intravenous sedation followed by conversion to general anesthesia if pain continues. These treatments represent standard care options for managing severe pain during cesarean sections. The trial assesses these approaches during hospitalization and up to six weeks after delivery. During the study, participants will be monitored from hospital admission through delivery and up to six weeks postpartum. Assessments include mental health evaluations, quality of recovery, pain severity and duration, satisfaction with anesthesia, adverse events, length of hospital stay, and need for intensive care. The primary outcome is consent from hospital admission through delivery, with secondary outcomes focusing on eligibility, randomization, recovery quality, pain, safety, and new PTSD symptoms at six weeks post-delivery.

Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study