NCT03120780

Brief Summary

This study is being done to investigate if there is more effective pain relief during the latter stages of labor and delivery when epidural fentanyl 100mcg is administered compared to epidural fentanyl 20mcg.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2024

Completed
Last Updated

March 27, 2025

Status Verified

January 1, 2024

Enrollment Period

7.4 years

First QC Date

April 10, 2017

Last Update Submit

March 24, 2025

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • VRS Pain Score

    VRS Pain score

    30 minutes after epidural bolus

Secondary Outcomes (5)

  • VRS Pain Score

    At Time of Delivery

  • Mode of Delivery

    At Time of Delivery

  • Patient Satisfaction

    During labor until post-partum day one

  • Adverse Events

    During labor until post-partum day one

  • Rescue Epidural Boluses

    Until delivery

Study Arms (2)

Low Dose Fentanyl

ACTIVE COMPARATOR

Low dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 20 mcg fentanyl (Fentanyl 20 mcg)

Drug: Fentanyl 20 mcg

High Dose Fentanyl

EXPERIMENTAL

High dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 100 mcg fentanyl (Fentanyl 100 mcg)

Drug: Fentanyl 100 mcg

Interventions

Fentanyl 20 mcgDRUG

20 mcg fentanyl in 10 mL 0.125% bupivacaine

Also known as: Low Dose
Low Dose Fentanyl
Fentanyl 100 mcgDRUG

100 mcg fentanyl in 10 mL 0.125% bupivacaine

Also known as: High Dose
High Dose Fentanyl

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMust be pregnant woman to considered for study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nulliparous women
  • Spontaneous labor
  • A single vertex presentation fetus at term (38-42 weeks)
  • Effective labor epidural analgesia with continuous epidural infusion established
  • Provide written consent to participate in the study.

You may not qualify if:

  • Multigravida women
  • Multigestation pregnancies
  • Patients being treated/managed for chronic pain
  • Allergies or significant adverse reactions to local anesthetic or opioid medications
  • Inadequate or unsatisfactory labor epidural analgesia
  • Patients with history of spine abnormalities or spine surgery
  • Non-English speaking
  • Prisoners
  • Age less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

FentanylContraceptives, Oral

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • John Coffman, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The subject and the research personnel will be blinded to the arm to which they are randomized. Only the clinician assessing the patient and administering epidural doses will be not be blinded to the study group.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Subjects will be randomly assigned to one of two groups: one group will receive lower dose epidural fentanyl (20 micrograms) combined with local anesthetic; and one group will receive higher-dose epidural fentanyl (100micrograms) combined with the same amount of local anesthetic.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Clinical

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 19, 2017

Study Start

June 26, 2017

Primary Completion

November 13, 2024

Study Completion

November 13, 2024

Last Updated

March 27, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

No plan to share IPD.

Locations

US(1)