Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery (NCT02417038) | Clinical Trial Compass
CompletedNot Applicable
Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery
United States80 participantsStarted 2015-04
Plain-language summary
Respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are given.Pathophysiological respiratory depression -failure to respond to hypercapnia or hypoxia - is challenging to measure clinically.American Society of Anesthesiologist guidelines recommend suitable respiratory monitoring for 24 hours post cesarean delivery (CD).
Use of capnograph will enable us to assess breath-by-breathe respiration in a population receiving neuraxial opioids - potentially at risk for respiratory depression.
Our aim is to assess our ability to capture maternal postpartum respiratory parameters in a cohort following opioid neuraxial administration for CD.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* American Society of Anesthesiologists physical status class I or II
* Age between 18 and 45
* Gestational age greater than 37 completed weeks
* Singleton pregnancy.
Exclusion Criteria:
* Contraindication for neuraxial analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
* Allergies to postoperative medication (opioids, NSAIDs, acetaminophen)
* Chronic opioid use
* Opioid administration in the previous 12 hours
* Inability to adequately understand the consent form
* Blocked nose or nasal deformity.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.