NCT07187427

Incidence of Pruritus Using Intrathecal Fentanyl Versus Epidural Fentanyl to Initiate Labour Analgesia.

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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
• Fentanyl Analgesia
• Fentanyl Adverse Reaction

Interventions

Type	Name	Description
PROCEDURE	Spinal analgesia	All procedures performed will be standardized. When neuraxial analgesia is required, an non-implicated anesthesiologist will performe the technique (not blind) The procedure will involve two steps. The first will involve an intraspinal injection of the solution using a 25-gauge Whitacre needle, while the second will be administered through the epidural catheter. STEP 1: Intraspinal SPINAL Group: Bupivacaine 0.25% Isobaric 1 ml + Fentanyl 15 mcg, (0,3ml) STEP 2: Epidural SPINAL group: 0.9% NaCl 2 ml.
PROCEDURE	Epidural Analgesia	All procedures performed will be standardized. When neuraxial analgesia is required, an non-implicated anesthesiologist will performe the technique (not blind) The procedure will involve two steps. The first will involve an intraspinal injection of the solution using a 25-gauge Whitacre needle, while the second will be administered through the epidural catheter. STEP 1: Intraspinal EPI Group: Bupivacaine 0.25% Isobaric 1 ml + NaCl 0.9% 0.3 ml STEP 2: Epidural EPI group: Fentanyl 100 mcg, (2 ml of a concentration of 50 mcg/ml)

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2025-09-23
• Last updated: 2025-11-26

Locations

1 site across 1 country: Canada