NCT07340970

Sensory Stimuli During Cesarean Delivery

Patient Perception of Sensory Stimuli During Elective Cesarean Delivery Under Neuraxial Anesthesia (PIONEER)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 310 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Intraoperative Pain

Interventions

Type	Name	Description
OTHER	Standardized intraoperative and postoperative patient-reported assessments	Brief patient self-assessments at six intraoperative time points (questions + VAS + diagram), and postoperative questionnaires (PDI, EPDS, PCL-5) through 6 months postpartum.

Timeline

• Start date: 2026-05-11
• Primary completion: 2027-05-30
• Completion: 2027-09-30
• First posted: 2026-01-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Canada