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NOT YET RECRUITING
NCT07187427
NA

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

Sponsor: St. Justine's Hospital

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-01

Completion Date

2027-05

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

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)

Locations (1)

Centre Hospitalier Universitaire de Sainte Justine

Montreal, Quebec, Canada