Sensory Stimuli During Cesarean Delivery (PIONEER)

University of British Columbia

Status: Not yet enrolling

Conditions: Intraoperative Pain

Treatments: Other: Standardized intraoperative and postoperative patient-reported assessments

Study type: Observational

Funder types: Other

Identifiers

NCT07340970

H25-02656

Details and patient eligibility

About

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.

Full 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.

Enrollment: 310 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy pregnant patients ≥36 weeks gestational age
• ASA Physical Status Class 2-3
• Elective cesarean delivery
• Age ≥19 years
• English-speaking

Exclusion criteria

• Known history of chronic pain or pain disorders
• Currently taking medications with analgesic properties
• Known history of neurological conditions that may impair normal sensation
• Cesarean delivery requiring epidural top-up or de novo general anesthesia

Trial design

310 participants in 1 patient group

Single cohort

Description:

Healthy patient undergoing elective cesarean delivery under neuraxial anesthesia

Treatment:

Other: Standardized intraoperative and postoperative patient-reported assessments