The Effect of Low-Dose vs High-Dose Epidural Fentanyl on Gastric Emptying - A Prospective Double-Blinded Randomized Controlled Trial

• Status: Active, not recruiting
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study investigates the effect of epidural fentanyl on gastric emptying in non-fasted laboring women. Half the women will be randomized to receive low-dose epidural fentanyl (<100 mcg), and half will be randomized to receive high-dose epidural fentanyl (≥100 mcg). Gastric content will be measured by ultrasonography two hours after epidural placement and compared between the groups.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Laboring women ≥18 years of age

• ≥37 weeks gestation

• Singleton pregnancy with cephalad fetus

• Cervical dilatation less than 5cm

• Request for epidural analgesia

Exclusion Criteria:

• Contraindications to neuraxial analgesia

• Chronic opioid consumption

• Increased risk of emergency cesarean delivery - Trial of labor after cesarean delivery (TOLAC), twin pregnancy, non-reassuring fetal heart rate (NRFHR), dysfunctional labor, estimated fetal weight>4000g, body mass index (BMI) ≥ 40kg/m2.

• Increased risk of aspiration - Disorders of the upper gastrointestinal tract (severe gastro-esophageal reflux, history of bariatric surgery), neurological and endocrine disorders associated with gastroparesis (such as multiple sclerosis, diabetes with autonomic neuropathy)

• BMI > 40kg/m2