Intraoperative Comfort After Cesarean with Neuraxial Anesthesia
Official title: Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia: Phase I of the Intraoperative Comfort Assessment Tool (ICAT) Validation
Run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · NCT07867106 · Data updated 2026-11-12
This study tests how patients feel during cesarean delivery with spinal or epidural anesthesia to help create a tool that captures intraoperative comfort.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | October 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07867106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults having elective or non-emergent cesarean deliveries with spinal, epidural, or combined spinal-epidural anesthesia who can communicate in English.
✕Probably not a fit
Patients who have severe maternal illness, cognitive impairment, inability to complete procedures, or those evaluated more than 36 hours after delivery may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will interview 20–30 women who recently had a cesarean delivery under spinal or epidural anesthesia to document the sensations they experienced during surgery. The goal is to develop a patient-reported measure of intraoperative discomfort that can inform real-time care and quality improvements. Interviews will explore sensations such as pressure, tugging, and nausea, and how patients distinguish these feelings from pain. The work is a first step toward a standardized tool called the Intraoperative Comfort Assessment Tool (ICAT).
Why it matters
Potential benefit: If successful, the study could lead to a validated way for care teams to assess and address intraoperative discomfort during cesarean deliveries.
How similar studies have gone: There is no existing validated instrument for intraoperative discomfort in cesarean delivery; this approach is exploratory and foundational.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults undergoing elective or non-emergent cesarean delivery with Pfannenstiel or transverse incision, under spinal, epidural, or combined spinal-epidural anesthesia * Able to communicate in English. Exclusion Criteria * Severe maternal illness preventing participation * Cognitive impairment or inability to complete study procedures * \> 36 hours since cesarean delivery Exclusion Criteria: \-
Where it's running
-
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Fernanda Septimio Lanza Oliveira, MD — Mount Sinai Hospital
- Study coordinator: Fernanda Septimio Lanza Oliveira, MD
- Email: Fernanda.Oliveira@sinaihealth.ca
- Phone: 416-586-4800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.