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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single cohort | Healthy patient undergoing elective cesarean delivery under neuraxial anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized intraoperative and postoperative patient-reported assessments | Other | Brief patient self-assessments at six intraoperative time points (questions + VAS + diagram), and postoperative questionnaires (PDI, EPDS, PCL-5) through 6 months postpartum. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of enrollment until the date of cesarean delivery completed, assessed up to 1day. |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative description of unacceptable sensory stimuli | Thematic categorization of participant responses | From date of enrollment until the date of cesarean delivery completed, assessed up to 1day. |
| Severity of intraoperative sensory stimuli |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy pregnant patients ≥36 weeks gestational age undergoing elective cesarean delivery under neuraxial anesthesia at BC Women's Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliana Kruthof, MD, MSc, FRCPC | Contact | 604-875-2424 | 6335 | juliana.barrera@cw.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Juliana Kruthof, MD, MSc, FRCPC | Department of Anesthesia BC Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Women's Hospital | Vancouver | British Columbia | V6H3N1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40939978 | Background | Saulnier L, Chau A, Barrera J, Massey S. Influence of Planned Versus Unplanned Cesarean Delivery on Postpartum Peritraumatic Distress: A Prospective Observational Study. J Obstet Gynaecol Can. 2025 Nov;47(11):103114. doi: 10.1016/j.jogc.2025.103114. Epub 2025 Sep 10. | |
| 38070747 | Background | Jagodnik KM, Ein-Dor T, Chan SJ, Titelman Ashkenazy A, Bartal A, Barry RL, Dekel S. Screening for post-traumatic stress disorder following childbirth using the Peritraumatic Distress Inventory. J Affect Disord. 2024 Mar 1;348:17-25. doi: 10.1016/j.jad.2023.12.010. Epub 2023 Dec 7. |
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Sensation intensity rated using a 0-10 visual analog scale (VAS) at each intraoperative assessment time point.
| 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. | 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. | 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. | From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum. |
| Peritraumatic distress over time | Peritraumatic Distress Inventory (PDI) score measured longitudinally. | 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. | 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). | From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum. |
| 35332526 | Background | Stanford SER. What is 'genuine' failure of neuraxial anaesthesia? Anaesthesia. 2022 May;77(5):523-526. doi: 10.1111/anae.15723. Epub 2022 Mar 25. No abstract available. |
| 32799069 | Background | Mehdiratta JE, Saab R, Chen Z, Li YJ, Habib AS. Patient and procedural risk factors for increased postoperative pain after cesarean delivery under neuraxial anesthesia: a retrospective study. Int J Obstet Anesth. 2020 Nov;44:60-67. doi: 10.1016/j.ijoa.2020.07.006. Epub 2020 Jul 21. |
| 35325933 | Background | Plaat F, Stanford SER, Lucas DN, Andrade J, Careless J, Russell R, Bishop D, Lo Q, Bogod D. Prevention and management of intra-operative pain during caesarean section under neuraxial anaesthesia: a technical and interpersonal approach. Anaesthesia. 2022 May;77(5):588-597. doi: 10.1111/anae.15717. Epub 2022 Mar 24. |
| 27717633 | Background | Stanford SE, Bogod DG. Failure of communication: a patient's story. Int J Obstet Anesth. 2016 Dec;28:70-75. doi: 10.1016/j.ijoa.2016.08.001. Epub 2016 Aug 23. |
| 28577570 | Background | Lopez U, Meyer M, Loures V, Iselin-Chaves I, Epiney M, Kern C, Haller G. Post-traumatic stress disorder in parturients delivering by caesarean section and the implication of anaesthesia: a prospective cohort study. Health Qual Life Outcomes. 2017 Jun 2;15(1):118. doi: 10.1186/s12955-017-0692-y. |
| 18818022 | Background | Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24. |
| 33280087 | Background | Landau R, Richebe P. Tailoring postoperative pain management with a procedure-specific approach: how to best apply this concept to caesarean deliveries. Anaesthesia. 2021 May;76(5):587-589. doi: 10.1111/anae.15251. Epub 2020 Oct 14. No abstract available. |
| 40184602 | Background | Charles EA, Carter H, Stanford S, Blake L, Eley V, Carvalho B, Sultan P, Kua J, O'Carroll JE. Intraoperative Pain during Cesarean Delivery under Neuraxial Anesthesia: A Systematic Review and Meta-analysis. Anesthesiology. 2025 Jul 1;143(1):156-167. doi: 10.1097/ALN.0000000000005486. Epub 2025 Apr 4. |
| 35991734 | Background | Frank E, Sharpe EE, Kohn G, Kohl-Thomas B, Shaver C, Hofkamp MP. Predictors of intraoperative pain during cesarean delivery under regional anesthesia. Proc (Bayl Univ Med Cent). 2022 Jun 14;35(5):595-598. doi: 10.1080/08998280.2022.2086789. eCollection 2022. |
| 37865217 | Background | Sanchez J, Prabhu R, Guglielminotti J, Landau R. Pain during cesarean delivery: A patient-related prospective observational study assessing the incidence and risk factors for intraoperative pain and intravenous medication administration. Anaesth Crit Care Pain Med. 2024 Feb;43(1):101310. doi: 10.1016/j.accpm.2023.101310. Epub 2023 Oct 20. |