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Sensory Stimuli During Cesarean Delivery

Recruitingn/aAges 19 Years - anyFemaleUniversity of British Columbia
NCT07340970 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

During a cesarean delivery (C-section), most patients are awake and receive spinal or epidural anesthesia to block pain from the lower body. Even when this anesthesia works well, many patients still feel sensations during surgery, such as pulling, pressure, tugging, or, in some cases, pain. In the past, studies have mostly focused on whether patients felt "pain," and have often relied on patients remembering their experience afterward or on the surgical team's judgment of how the patient was doing. These approaches can miss sensations that bother the patient but are not clearly described as pain, and they may not reflect what the patient actually wanted done at the time. This study takes a different approach. Instead of asking only about pain, the researchers will ask patients, in real time during their C-section, what they are feeling in their own words, and whether they would like the

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📋 Eligibility rules (as published)
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
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What it tests

  • Patient-initiated request for pharmacological intervention during cesarean delivery
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Where

1 site
BC Women's Hospital
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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