Epidural Fentanyl for 2nd Stage Labor Analgesia

Labor Pain Clinical Trial

Official title:

High Dose Epidural Fentanyl for Second Stage Labor Analgesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03120780
• Other study ID #: 2016H0439
• Status: Recruiting
• Phase: Phase 4
• Start date: June 26, 2017
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: John Coffman, MD
• Phone: 614-293-8487
• Email: john.coffman[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The objective is to evaluate if high-dose epidural fentanyl (100 micrograms) is more effective at providing pain relief during the late first stage (>8 cm cervical dilation) and second stage of labor until the time of delivery compared to low-dose epidural fentanyl (20 micrograms). In this study, anesthetic care will be provided to a subject by an experienced anesthesia provider according to standard hospital care. If the subject has adequate pain relief from the continuous epidural infusion, then a study investigator will record the verbal pain score and document any other side effects at hourly intervals beginning at >8cm cervical dilation, but no additional epidural medications will be administered. If pain relief becomes inadequate during the late first or second stage of labor (>8cm cervical dilation) and a manual epidural bolus is required, then the subject will be randomly assigned to one of two groups (like flipping a coin): 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. Both doses are used frequently on labor and delivery and are considered to be safe based on available evidence. If there is not sufficient pain relief from the epidural medication given, then an experienced anesthesia provider will assess if another epidural dose may be effective and this additional epidural medication will be given at the discretion of the anesthesia provider. An experienced anesthesia provider will be available at all times during the study to assess pain and provide epidural medications. All patients participating in the study will have their pain scores assessed every hour as soon as the cervical dilation is noted to be >8cm; at the time of randomization; and at 10, 20, 30 and 60 minutes after the epidural dose is administered. The presence of any side-effects such as itching, shivering, nausea, vomiting, low blood pressure, slow respiratory rate or lower extremity muscle weakness will also be collected at hourly intervals as soon as the cervical dilation is noted to be >8cm. Subject satisfaction (1-100 rating scale) with anesthetic care provided will be assessed on postpartum day # 1 during routine follow-up visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Nulliparous women

2. Spontaneous labor

3. A single vertex presentation fetus at term (38-42 weeks)

4. Effective labor epidural analgesia with continuous epidural infusion established

5. Provide written consent to participate in the study.

Exclusion Criteria:

1. Multigravida women

2. Multigestation pregnancies

3. Patients being treated/managed for chronic pain

4. Allergies or significant adverse reactions to local anesthetic or opioid medications

5. Inadequate or unsatisfactory labor epidural analgesia

6. Patients with history of spine abnormalities or spine surgery

7. Non-English speaking

8. Prisoners

9. Age less than 18 years old

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Fentanyl 20 mcg
20 mcg fentanyl in 10 mL 0.125% bupivacaine
• Fentanyl 100 mcg
100 mcg fentanyl in 10 mL 0.125% bupivacaine

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VRS Pain Score	VRS Pain score	30 minutes after epidural bolus
Secondary	VRS Pain Score	VRS Pain Score	At Time of Delivery
Secondary	Mode of Delivery	Mode of Delivery (cesarean, spontaneous vaginal or assisted vaginal delivery)	At Time of Delivery
Secondary	Patient Satisfaction	Patient Satisfaction with Labor Pain Control (1-100 rating scale; 1= not satisfied at all, 100=completely satisfied)	During labor until post-partum day one
Secondary	Adverse Events	Nausea, vomiting, shivering, pruritis, hypotension, motor block, maternal respiratory depression, neonatal outcomes	During labor until post-partum day one
Secondary	Rescue Epidural Boluses	Total number of clinician administered epidural boluses during the late first (=8cm cervical dilation) and second stages of labor	Until delivery