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

NCT04202887 | Unknown DMC

• 1 other identifier: TASMC-19-CW-004019-CTIL
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy; Aspiration

Keywords

Anesthesia; Aspiration; Epidural opioids; Gastric ultrasound; Gastric emptying; Labor fasting guidelines

Outcome Measures

Primary Outcomes (1)

• CSA two hours after epidural placement

  CSA measured by ultrasonography two hours after first measurement (at T2h) in "High dose Fentanyl" (HF) versus "Low dose Fentanyl" (LF)

  2 hours after epidural placement

Secondary Outcomes (1)

• Change in CSA from baseline in HF versus LF

  Baseline and at 2 hours

Study Arms (2)

Low Fentanyl (LF)

ACTIVE COMPARATOR

fentanyl cumulative dose below 100mcg

Drug: Low Dose Fentanyl; Device: Gastric Ultrasonography

High Fentanyl (HF)

ACTIVE COMPARATOR

fentanyl cumulative dose above 100mcg

Drug: High Dose Fentanyl; Device: Gastric Ultrasonography

Interventions

Low Dose Fentanyl DRUG

10ml bolus: bupivacaine 0.1% + 25mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 1mcg/ml

Low Fentanyl (LF)

High Dose Fentanyl DRUG

10ml bolus: bupivacaine 0.1% + 100mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 2mcg/ml

High Fentanyl (HF)

Gastric Ultrasonography DEVICE

The Gastric US will be performed using a portable device with an abdominal probe by the same operator (EF) for all women. The Cross Sectional Area (CSA) of the antrum will be measured in the supine position with the head elevated 45 degrees. CSA will be calculated using the formula (AP x CC x pi)/4, where AC is the anterio-posterior diameter and CC the cranio-caudal diameter. Three consecutive measurements will be performed and the average of the three will be used as the final data. The cutoff used to define a "full stomach" will be a CSA above 381 mm2, which has been validated in previous studies on laboring woman. Gastric US will be performed immediately after verification of effective epidural analgesia (T0) and intrapartum, two hours after the first measurement (T2h), corresponding to a cumulative dose of 37-97mcg fentanyl in Group LF and 124-240mcg fentanyl in Group HF.

High Fentanyl (HF); Low Fentanyl (LF)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboring women ≥18 years of age
• ≥37 weeks gestation
• Singleton pregnancy with cephalad fetus
• Cervical dilatation less than 5cm
• Request for epidural analgesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Related Publications (1)

• Fiszer E, Aptekman B, Baar Y, Weiniger CF. The effect of high-dose versus low-dose epidural fentanyl on gastric emptying in nonfasted parturients: A double-blinded randomised controlled trial. Eur J Anaesthesiol. 2022 Jan 1;39(1):50-57. doi: 10.1097/EJA.0000000000001514.

  PMID: 33852498 DERIVED

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Idit Matot, M.D.

  Tel-Aviv Sourasky Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants will be blinded to their group allocation. Upon request for labor epidural analgesia, the epidural will be performed by one of the anesthesiologists working in the delivery room who will receive an envelope with the woman's randomization. The investigator performing the gastric ultrasound will be blinded to the subject's randomization as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A double-blinded randomized controlled study

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: December 18, 2019
• Study Start: July 30, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)