Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment30 (estimated)
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedOctober 2026
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedOctober 9, 2026
Trial IDNCT07867106 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:

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Where it's running

  • Mount Sinai Hospital
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.