Randomized Trial Comparing the Injection of Intrathecal Fentanyl Versus Epidural Fentanyl for the Initiation of Labour Analgesia on the Incidence of Pruritis.

NCT07187427 NA NOT_YET_RECRUITING

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

Details

Lead sponsor	St. Justine's Hospital
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	80
Start date	2026-01
Completion	2027-05

Conditions

• Pruritis
• Hypotension Drug-Induced
• Urinary Retention
• Fetal Bradycardia During Labor
• Nausea and Vomitting
• Satisfaction, Patient
• Labor Analgesia
• Neuraxial Opioid
• Opioid Analgesic Adverse Reaction
• Term Labour

Interventions

• Spinal analgesia
• Epidural Analgesia

Primary outcomes

• Pruritus — Every 15 minutes for the first hour, then every 30min for 2 hours until neuraxial analgesia
  Incidence et severity * 4-point Likert scale: Absent, light, moderate, severe/unbearable. * number of patients treated by antipruritic (Naloxone)

Countries

Canada