Sensory Stimuli During Cesarean Delivery (PIONEER)

April 11, 2026 updated by: Juliana Barrera, University of British Columbia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H3N1
        • BC Women's Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Roanne Preston, MD, FRCPC
        • Principal Investigator:
          • Juliana Kruthof, MD, MSc, FRCPC
        • Sub-Investigator:
          • William Shippam, MBChB, FRCA, FRCPC
        • Sub-Investigator:
          • Kathryn Clark, MD, FRCPC
        • Sub-Investigator:
          • Katherine M Seligman, MD, FRCPC D.ABA
        • Sub-Investigator:
          • Simon Massey, FRCA, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy pregnant patients ≥36 weeks gestational age undergoing elective cesarean delivery under neuraxial anesthesia at BC Women's Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single cohort
Healthy patient undergoing elective cesarean delivery under neuraxial anesthesia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of intraoperative sensory stimuli perceived as unacceptable
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.
From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative description of unacceptable sensory stimuli
Time Frame: From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
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
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.
From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
Total intraoperative supplemental IV analgesia received
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.
From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
PTSD symptoms over time
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.
From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.
Depressive symptoms over time
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.
From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.
Peritraumatic distress over time
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.
From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.
Postoperative pain intensity (NRS)
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.
From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum.
In-hospital opioid requirement (MME)
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).
From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Juliana Kruthof, MD, MSc, FRCPC, Department of Anesthesia BC Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 11, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H25-02656

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intraoperative Pain

Clinical Trials on Standardized intraoperative and postoperative patient-reported assessments

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe