Sensory Experiences During Cesarean Delivery with Neuraxial Anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study will enroll adults undergoing elective cesarean delivery with spinal or spinal-epidural anesthesia. Patients will report in real time what they feel during surgery and indicate if they want pain-relieving actions taken. The research team will document patient-reported sensations and the corresponding clinical responses without influencing standard care. Follow-up questionnaires will assess longer-term outcomes at 6 weeks, 3 months, and 6 months after delivery. The study uses a common protocol across centers to ensure consistent data collection while adhering to ethical guidelines.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pregnant and 19 years of age or older
* Single (one) baby at 37 weeks of pregnancy or later
* Overall health classified as American Society of Anesthesiologists (ASA) Physical Status II or III
* Scheduled for a planned (elective) cesarean delivery using spinal anesthesia (single-shot spinal or combined spinal-epidural)
* Able to describe sensations in their own words in one of the study's available languages
* Willing and able to give written informed consent before any study procedures
* Willing and able to complete online follow-up questionnaires at 6 weeks, 3 months, and 6 months after delivery

Exclusion Criteria:

* History of a chronic pain condition (for example, fibromyalgia, chronic pelvic pain, complex regional pain syndrome, or chronic low back pain requiring ongoing treatment)
* Regular use of opioids, gabapentinoids (gabapentin or pregabalin), or other centrally acting pain medications during the current pregnancy (occasional acetaminophen use is allowed)
* History of a neurological condition that can affect normal sensation (for example, peripheral neuropathy, multiple sclerosis, or spinal cord injury)
* Pregnancy with more than one baby (twins or more)
* Cesarean delivery planned with an anesthesia method other than single-shot spinal or combined spinal-epidural (for example, topping up an existing labor epidural, or general anesthesia)
* Known major fetal abnormality or an expected newborn complication likely to require immediate admission to the neonatal intensive care unit (NICU)
* Known allergy or other reason the local anesthetic medications used for spinal anesthesia cannot be given
* Active substance use disorder

Where it's running

• BC Women's Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Juliana Kruthof, MD, MSc, FRCPC — Department of Anesthesia BC Women's Hospital
• Study coordinator: Juliana Kruthof, MD, MSc, FRCPC
• Email: juliana.barrera@cw.bc.ca
• Phone: 604-875-2424

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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.