Epidural Fentanyl for 2nd Stage Labor Analgesia

NCT ID: NCT03120780

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-26
• Study Completion Date: 2024-11-13

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.

Detailed 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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Low Dose Fentanyl

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

Group Type: ACTIVE_COMPARATOR

Fentanyl 20 mcg

Intervention Type: DRUG

20 mcg fentanyl in 10 mL 0.125% bupivacaine

High Dose Fentanyl

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

Group Type: EXPERIMENTAL

Fentanyl 100 mcg

Intervention Type: DRUG

100 mcg fentanyl in 10 mL 0.125% bupivacaine

Interventions

Fentanyl 20 mcg

20 mcg fentanyl in 10 mL 0.125% bupivacaine

Intervention Type: DRUG

Fentanyl 100 mcg

100 mcg fentanyl in 10 mL 0.125% bupivacaine

Intervention Type: DRUG

Other Intervention Names

Low Dose; High Dose

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Goran Ristev

Assistant Professor - Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Coffman, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2016H0439

Identifier Type: -

Identifier Source: org_study_id