NCT Number: NCT07340970
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.
Trial opening soon.
Get Notified19 year and older
Female
Observational
Vancouver, British Columbia, V6H3N1, Canada
Juliana Kruthof, MD, MSc, FRCPC
CONTACT
604-875-2158 ext. 6335
Juliana Kruthof, MD, MSc, FRCPC
PRINCIPAL_INVESTIGATOR
Katherine M Seligman, MD, FRCPC D.ABA
SUB_INVESTIGATOR
Kathryn Clark, MD, FRCPC
SUB_INVESTIGATOR
Roanne Preston, MD, FRCPC
SUB_INVESTIGATOR
Simon Massey, FRCA, FRCPC
CONTACT
604-875-2158 ext. 6335
Simon Massey, FRCA, FRCPC
SUB_INVESTIGATOR
William Shippam, MBChB, FRCA, FRCPC
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Brief patient self-assessments at six intraoperative time points (questions + VAS + diagram), and postoperative questionnaires (PDI, EPDS, PCL-5) through 6 months postpartum.
Time frame: From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
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.
Thematic categorization of participant responses
Time frame: From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
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 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 follow-up completion, assessed up to 6 months post-partum.
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.
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.
Peritraumatic Distress Inventory (PDI) score measured longitudinally.
Time frame: From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum.
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.
Total opioid dose administered from end of surgery until hospital discharge, converted to oral morphine milligram equivalents (MME).
Contact information is provided by the study sponsor or research team.
University of British Columbia
Other
Patient Perception of Sensory Stimuli During Elective Cesarean Delivery Under Neuraxial Anesthesia (PIONEER)
Acronym: PIONEER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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