Status:
NOT_YET_RECRUITING
Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.
Lead Sponsor:
St. Justine's Hospital
Conditions:
Pruritis
Hypotension Drug-Induced
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 wi...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Vaginal delivery
- Gestational age ≥ 37 weeks
- Requesting neuraxial analgesia
- French or English language
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07187427
Start Date
January 1 2026
End Date
May 1 2027
Last Update
November 26 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire de Sainte Justine
Montreal, Quebec, Canada, H3T 1C5