Labor PainPhase 4NCT03120780
Epidural Fentanyl for 2nd Stage Labor Analgesia
A Phase 4 study testing Fentanyl 20 mcg and Fentanyl 100 mcg in people with Labor Pain, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Fentanyl 20 mcg and Fentanyl 100 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 13 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Non-English speaking
- Prisoners
- Age less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: High Dose Epidural Fentanyl for Second Stage Labor Analgesia
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.
Read the 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
- Being tested
- Fentanyl 20 mcg, Fentanyl 100 mcg
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl 20 mcgDrug
Also called Low Dose
20 mcg fentanyl in 10 mL 0.125% bupivacaine
Fentanyl 100 mcgDrug
Also called High Dose
100 mcg fentanyl in 10 mL 0.125% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Fentanyl 100 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
VRS Pain Score
VRS Pain score
Measured: 30 minutes after epidural bolus
Secondary outcomes (5)
VRS Pain Score
VRS Pain Score
Measured: At Time of Delivery
Mode of Delivery
Mode of Delivery (cesarean, spontaneous vaginal or assisted vaginal delivery)
Measured: At Time of Delivery
Patient Satisfaction
Patient Satisfaction with Labor Pain Control (1-100 rating scale; 1= not satisfied at all, 100=completely satisfied)
Measured: During labor until post-partum day one
Adverse Events
Nausea, vomiting, shivering, pruritis, hypotension, motor block, maternal respiratory depression, neonatal outcomes
Measured: During labor until post-partum day one
Rescue Epidural Boluses
Total number of clinician administered epidural boluses during the late first (≥8cm cervical dilation) and second stages of labor
Measured: Until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start26 Jun 2017
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Why it stopped: Due to change on standard of care, higher doses of fentanyl requirements are rare.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Ristev, Ohio State University
- Investigators
- John Coffman, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120780
- Sponsor's protocol ID
- 2016H0439
- Status last verified
- Jan 2024
- First submitted
- 10 Apr 2017
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Epidural Fentanyl for Second Stage Labor Analgesia
- ClinicalTrials.gov ID
- NCT03120780
- Acronym / sponsor ID
- 2016H0439
- Conditions
- Labor Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to change on standard of care, higher doses of fentanyl requirements are rare.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low Dose Fentanyl | Active comparator | Drug: Fentanyl 20 mcgLow dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 20 mcg fentanyl (Fentanyl 20 mcg) |
| High Dose Fentanyl | Experimental | Drug: Fentanyl 100 mcgHigh dose epidural fentanyl combined with local anesthetic as 10mL of 0.125% bupivacaine with 100 mcg fentanyl (Fentanyl 100 mcg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl 20 mcgAlso: Low Dose20 mcg fentanyl in 10 mL 0.125% bupivacaine | Drug | Low Dose Fentanyl |
| Fentanyl 100 mcgAlso: High Dose100 mcg fentanyl in 10 mL 0.125% bupivacaine | Drug | High Dose Fentanyl |
Primary outcome
VRS Pain Score
Time frame: 30 minutes after epidural bolus
VRS Pain score
5 secondary outcomes
VRS Pain Score
Time frame: At Time of Delivery
Mode of Delivery
Time frame: At Time of Delivery
Patient Satisfaction
Time frame: During labor until post-partum day one
Adverse Events
Time frame: During labor until post-partum day one
Rescue Epidural Boluses
Time frame: Until delivery
Results and safety
The study was stopped early (reason given: Due to change on standard of care, higher doses of fentanyl requirements are rare.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Coffman, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl 20 mcg and Fentanyl 100 mcg in people with Labor Pain, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to change on standard of care, higher doses of fentanyl requirements are rare.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VRS Pain Score (time frame: 30 minutes after epidural bolus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.