Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Anal… (NCT07187427) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.
Canada80 participantsStarted 2026-01
Plain-language summary
The purpose of this study is to investigate the effect of neuraxial analgesia initiation on the incidence of pruritus in laboring women. Specifically, this study aim to compare intrathecal fentanyl with epidural fentanyl in order to determine whether the epidural route is associated with a lower occurrence and severity of pruritus. By clarifying these differences, the research seek to optimize analgesic strategies during labor while minimizing opioid-related side effects
Who can participate
Age range
18 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:
* Age ≥ 18 years
* Vaginal delivery
* Gestational age ≥ 37 weeks
* Requesting neuraxial analgesia
* French or English language
Exclusion Criteria:
* ASA score \> 3
* Allergy or contraindication to receiving opioids/local anesthesia (morphine or fentanyl)
* BMI \> 40 kg/m²
* Hepatic or renal failure,
* Severe preeclampsia and signs of severity according to the criteria of the American College of Obstetricians and Gynecologists
* Maternal hemorrhage (placental abruption, hepatic subcapsular hematoma,...)
* Severe scoliosis
* Biliary cholestasis or polymorphic eruption of pregnancy
* Inability to provide informed consent, either secondary to mental or physical disability or a significant language barrier (inability to understand English or French)
* Prior administration of an opioid or opioid misuse
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.
What they're measuring
1
Pruritus
Timeframe: Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia