This study will follow people having a planned cesarean birth with a spinal or combined spinal-epidural anesthetic. The investigators will ask what kinds of sensations participants feel during the operation, how often these happen, and whether any of the sensations feel as unacceptable or too uncomfortable. Participants will be asked a few short questions at six set times during the surgery. Participants will also complete short questionnaires before surgery and again after birth (up to 6 months) to help us understand mood, stress, and overall wellbeing.
Cesarean delivery is common and neuraxial anesthesia is the standard technique; however, a meaningful proportion of patients experience intraoperative pain or distressing sensations. Existing research often relies on retrospective recall, surrogate markers (e.g., medication use), and variable definitions of intraoperative pain, with limited prospective characterization of the sensory experiences that patients perceive and whether participants interpret them as painful or otherwise unacceptable. PIONEER is a prospective, longitudinal cohort study enrolling healthy pregnant patients undergoing elective cesarean delivery at BC Women's Hospital. The primary objective is to estimate the incidence of intraoperative sensory stimuli that are self-reported as unacceptable (i.e., sensations the participant reports as unacceptable and needing treatment). Intraoperative data will be collected at six defined surgical milestones from block confirmation to skin closure via short patient questions. Postoperative and longitudinal follow-up will assess postpartum distress, depression, and PTSD symptoms. Clinical care is not directed by the study; anesthetic and surgical management remains at the discretion of the treating team.
Study Type
OBSERVATIONAL
Enrollment
310
Brief patient self-assessments at six intraoperative time points (questions + VAS + diagram), and postoperative questionnaires (PDI, EPDS, PCL-5) through 6 months postpartum.
BC Women's Hospital
Vancouver, British Columbia, Canada
Incidence of intraoperative sensory stimuli perceived as unacceptable
Proportion of participants who report experiencing any intraoperative sensory stimulus that they subjectively self-report as unacceptable.
Time frame: From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
Qualitative description of unacceptable sensory stimuli
Thematic categorization of participant responses
Time frame: From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
Severity of intraoperative sensory stimuli
Sensation intensity rated using a 0-10 visual analog scale (VAS) at each intraoperative assessment time point.
Time frame: From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
Total intraoperative supplemental IV analgesia received
Total dose(s) of supplemental IV analgesic medications administered intraoperatively, abstracted from the medical record/anesthesia record.
Time frame: From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
PTSD symptoms over time
PTSD Checklist for DSM-5 (PCL-5) score measured longitudinally.
Time frame: From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.
Depressive symptoms over time
Edinburgh Postnatal Depression Scale (EPDS) score measured longitudinally.
Time frame: From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.
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Peritraumatic distress over time
Peritraumatic Distress Inventory (PDI) score measured longitudinally.
Time frame: From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.
Postoperative pain intensity (NRS)
0-10 Numerical Rating Scale (NRS) pain scores collected during the first 48 hours of admission, per clinical charting.
Time frame: From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum.
In-hospital opioid requirement (MME)
Total opioid dose administered from end of surgery until hospital discharge, converted to oral morphine milligram equivalents (MME).
Time frame: From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum.