Labor PainPhase 4NCT03623256
Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
A Phase 4 study testing Spinal fentanyl, Spinal bupivacaine and Spinal Fentanyl and Bupivacaine in people with Labor Pain and Obstetric Pain, run by Augusta University at 1 site in United States.
Trial summary
There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Pain, Obstetric Pain
- What is being tested?
- Spinal fentanyl, Spinal bupivacaine and Spinal Fentanyl and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 31 Oct 2023
- 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
- Older than 18 years
- Term pregnancy (> 37 weeks)
- Absence of obstetric morbidities
- Active labor
- Request of neuraxial analgesia per patient and/or obstetrician
- Combined spinal-epidural technique
Who cannot join
- Abnormal fetal heart rate tracing.
- Uterine tachysystole before neuraxial analgesia.
- Baseline blood pressure <90/60 mmHg.
- Allergies to local anesthetics or fentanyl.
- Maternal fever.
- Pruritus before performance of neuraxial analgesia.
- Contraindications for neuraxial technique.
- Unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
Steffen Meiler, MD, 706-721-3671, smeiler@augusta.edu
About this study
Official title: Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Some authors have reported cases of parturients who developed uterine hyperactivity and fetal bradycardia after subarachnoid administration of fentanyl during labor. (D'Angelo \& Eisenach, 1997) (Friedlander JD, 1997). It has been suggested that uterine hypertonus, leading to non-reassuring fetal heart rate tracings, might be an etiologic factor in these situations. (Landau, 2002).
We propose this study to test the hypothesis that administration of epidural fentanyl is associated with a lower incidence of fetal bradycardia compared to intrathecal fentanyl.
Read the detailed description
After approval by the Institutional Review Board and written informed consent, we plan to prospectively study pregnant patients who undergo neuraxial labor analgesia. All patients will receive combined-spinal-epidural analgesia. Patients will be randomly assigned to one of four groups by means of sealed envelope technique. Group A will receive a spinal dose of preservative-free fentanyl 25 mcg. Group B will receive one dose of spinal preservative-free 0.25% bupivacaine. Group C will receive a spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg. Group D will receive spinal preservative-free 0.25% bupivacaine and epidural fentanyl 100 mcg. After the procedure, we will monitor the fetal heart rate and tocometry tracings for 20 min. Thereafter, an epidural infusion with a solution containing 0.125% bupivacaine and 2mcg/mL of fentanyl will be started. We will record demographic variables (age, and BMI), obstetric variables (parity, gestational age, cervical dilation, oxytocin infusion) and anesthetic variables (level of insertion of epidural catheter).
Primary outcomes:
Fetal heart rate (baseline, minimal and abnormal patterns)
Secondary outcomes:
- Blood pressure (systolic, diastolic and mean) measured at baseline and every 5 minutes after administration of medication.
- Dermatomal level measured after 20 minutes of medication administration.
- Pain level (visual analogue scale) after 20 minutes of medication administration.
- Patient satisfaction level (1-10 scale) after 20 minutes of medication administration.
- Uterine tone measured with tocometer at baseline and during 20 minutes after medication administration.
- Conditions
- Labor Pain, Obstetric Pain
- Being tested
- Spinal fentanyl, Spinal bupivacaine, Spinal Fentanyl and Bupivacaine, Epidural fentanyl /spinal bupivacaine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal fentanylDrug
Also called Fentora
25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.
Spinal bupivacaineDrug
Also called Marcaine
1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route.
Spinal Fentanyl and BupivacaineDrug
Also called Marcaine and Fentora
1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL), and 25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.
Epidural fentanyl /spinal bupivacaineDrug
Also called Marcaine and Fentora
1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route, and 100 mcg of fentanyl (2 mL) will be administered by epidural route.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Fentanyl | Active comparator | Spinal dose of preservative-free fentanyl 25 mcg (Volume 0.5 mL) Receives: Drug: Spinal fentanyl |
| Spinal Bupivacaine | Active comparator | Spinal dose of preservative-free 0.25% bupivacaine (Volume 0.5 mL) Receives: Drug: Spinal bupivacaine |
| Spinal Fentanyl and Bupivacaine | Active comparator | Spinal combination of preservative-free 0.25% bupivacaine (0.5 mL) and fentanyl 25 mcg (0.5 mL). (Total Volume 1 mL). Receives: Drug: Spinal Fentanyl and Bupivacaine |
| Epidural fentanyl /spinal bupivacaine | Experimental | Spinal preservative-free 0.25% bupivacaine (Volume 0.5 mL) and epidural fentanyl 100 mcg (Volume 2 mL). Receives: Drug: Epidural fentanyl /spinal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal heart rate
Fetal bradycardia and abnormal fetal heart rate tracing
Measured: 20 minutes (Starting from placement of labor neuraxial block)
Secondary outcomes (5)
Blood pressure
Maternal systolic, diastolic and mean arterial pressure measured at baseline and every 5 minutes after administration of medication
Measured: 20 minutes (Starting from placement of labor neuraxial block)
Dermatomal level
Analgesic level measured by sensitivity to temperature stimulus
Measured: 20 minutes (Starting from placement of labor neuraxial block)
Maternal Pain level: visual analogue scale
Pain evaluated by visual analogue scale (0, no pain; 10, worst pain)
Measured: 20 minutes (Starting from placement of labor neuraxial block)
Patient satisfaction level: Likert Scale
Satisfaction level measured by Likert Scale (5: fully satisfied, 4: satisfied, 3: neutral, 2: dissatisfied, 1: fully dissatisfied)
Measured: 20 minutes (Starting from placement of labor neuraxial block)
Uterine tone
Measured with tocometer (In milimeters above baseline) at baseline and during 20 minutes after medication administration.
Measured: 20 minutes (Starting from placement of labor neuraxial block)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start28 Oct 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
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.
- 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
- Patients will be randomly assigned to one of four groups: Group A: Spinal dose of preservative-free fentanyl 25 mcg. Group B: Spinal preservative-free 0.25% bupivacaine. Group C: Spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg. Group D: Spinal preservative-free 0.25% bupivacaine and epidural fentanyl 100 mcg. After the procedure, we will monitor the fetal heart rate and tocometry tracings for 30 min. Thereafter, an epidural infusion with a solution containing 0.125% bupivacaine and 2mcg/mL of fentanyl will be started. We will record demographic variables (age, and BMI), obstetric variables (parity, gestational age, cervical dilation, oxytocin infusion) and anesthetic variables (level of insertion of epidural catheter). We will also record level of insertion, blood pressure every 5 minutes, dermatomal level, pain level, patient satisfaction level and pruritus.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
- Investigators
- Efrain Riveros Perez, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623256
- Sponsor's protocol ID
- 1238162
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team will decide about sharing information upon request
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrathecal Versus Epidural Fentanyl: Effect of Neuraxial Route of Administration on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
- ClinicalTrials.gov ID
- NCT03623256
- Acronym / sponsor ID
- 1238162
- Conditions
- Labor Pain, Obstetric Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 9 Aug 2018 (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.
There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Some authors have reported cases of parturients who developed uterine hyperactivity and fetal bradycardia after subarachnoid administration of fentanyl during labor. (D'Angelo \& Eisenach, 1997) (Friedlander JD, 1997). It has been suggested that uterine hypertonus, leading to non-reassuring fetal heart rate tracings, might be an etiologic factor in these situations. (Landau, 2002).
We propose this study to test the hypothesis that administration of epidural fentanyl is associated with a lower incidence of fetal bradycardia compared to intrathecal fentanyl.
Detailed description
After approval by the Institutional Review Board and written informed consent, we plan to prospectively study pregnant patients who undergo neuraxial labor analgesia. All patients will receive combined-spinal-epidural analgesia. Patients will be randomly assigned to one of four groups by means of sealed envelope technique. Group A will receive a spinal dose of preservative-free fentanyl 25 mcg. Group B will receive one dose of spinal preservative-free 0.25% bupivacaine. Group C will receive a spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg. Group D will receive spinal preservative-free 0.25% bupivacaine and epidural fentanyl 100 mcg. After the procedure, we will monitor the fetal heart rate and tocometry tracings for 20 min. Thereafter, an epidural infusion with a solution containing 0.125% bupivacaine and 2mcg/mL of fentanyl will be started. We will record demographic variables (age, and BMI), obstetric variables (parity, gestational age, cervical dilation, oxytocin infusion) and anesthetic variables (level of insertion of epidural catheter).
Primary outcomes:
Fetal heart rate (baseline, minimal and abnormal patterns)
Secondary outcomes:
- Blood pressure (systolic, diastolic and mean) measured at baseline and every 5 minutes after administration of medication.
- Dermatomal level measured after 20 minutes of medication administration.
- Pain level (visual analogue scale) after 20 minutes of medication administration.
- Patient satisfaction level (1-10 scale) after 20 minutes of medication administration.
- Uterine tone measured with tocometer at baseline and during 20 minutes after medication administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Patients will be randomly assigned to one of four groups: Group A: Spinal dose of preservative-free fentanyl 25 mcg. Group B: Spinal preservative-free 0.25% bupivacaine. Group C: Spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg. Group D: Spinal preservative-free 0.25% bupivacaine and epidural fentanyl 100 mcg. After the procedure, we will monitor the fetal heart rate and tocometry tracings for 30 min. Thereafter, an epidural infusion with a solution containing 0.125% bupivacaine and 2mcg/mL of fentanyl will be started. We will record demographic variables (age, and BMI), obstetric variables (parity, gestational age, cervical dilation, oxytocin infusion) and anesthetic variables (level of insertion of epidural catheter). We will also record level of insertion, blood pressure every 5 minutes, dermatomal level, pain level, patient satisfaction level and pruritus.
| Arm | Type | Receives |
|---|---|---|
| Spinal Fentanyl | Active comparator | Drug: Spinal fentanylSpinal dose of preservative-free fentanyl 25 mcg (Volume 0.5 mL) |
| Spinal Bupivacaine | Active comparator | Drug: Spinal bupivacaineSpinal dose of preservative-free 0.25% bupivacaine (Volume 0.5 mL) |
| Spinal Fentanyl and Bupivacaine | Active comparator | Drug: Spinal Fentanyl and BupivacaineSpinal combination of preservative-free 0.25% bupivacaine (0.5 mL) and fentanyl 25 mcg (0.5 mL). (Total Volume 1 mL). |
| Epidural fentanyl /spinal bupivacaine | Experimental | Drug: Epidural fentanyl /spinal bupivacaineSpinal preservative-free 0.25% bupivacaine (Volume 0.5 mL) and epidural fentanyl 100 mcg (Volume 2 mL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older than 18 years
- Term pregnancy (> 37 weeks)
- Absence of obstetric morbidities
- Active labor
- Request of neuraxial analgesia per patient and/or obstetrician
Key exclusion criteria (8 listed)
- Abnormal fetal heart rate tracing.
- Uterine tachysystole before neuraxial analgesia.
- Baseline blood pressure <90/60 mmHg.
- Allergies to local anesthetics or fentanyl.
- Maternal fever.
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 |
|---|---|---|
| Spinal fentanylAlso: Fentora25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route. | Drug | Spinal Fentanyl |
| Spinal bupivacaineAlso: Marcaine1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route. | Drug | Spinal Bupivacaine |
| Spinal Fentanyl and BupivacaineAlso: Marcaine and Fentora1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL), and 25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route. | Drug | Spinal Fentanyl and Bupivacaine |
| Epidural fentanyl /spinal bupivacaineAlso: Marcaine and Fentora1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route, and 100 mcg of fentanyl (2 mL) will be administered by epidural route. | Drug | Epidural fentanyl /spinal bupivacaine |
Primary outcome
Fetal heart rate
Time frame: 20 minutes (Starting from placement of labor neuraxial block)
Fetal bradycardia and abnormal fetal heart rate tracing
5 secondary outcomes
Blood pressure
Time frame: 20 minutes (Starting from placement of labor neuraxial block)
Dermatomal level
Time frame: 20 minutes (Starting from placement of labor neuraxial block)
Maternal Pain level: visual analogue scale
Time frame: 20 minutes (Starting from placement of labor neuraxial block)
Patient satisfaction level: Likert Scale
Time frame: 20 minutes (Starting from placement of labor neuraxial block)
Uterine tone
Time frame: 20 minutes (Starting from placement of labor neuraxial block)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: Undecided. The study team will decide about sharing information upon request
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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.
Efrain Riveros Perez, MD principal investigator
Augusta 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 Spinal fentanyl, Spinal bupivacaine and Spinal Fentanyl and Bupivacaine in people with Labor Pain and Obstetric Pain, run by Augusta 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efrain Riveros Perez, MD (7067217361, eriverosperez@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal heart rate (time frame: 20 minutes (Starting from placement of labor neuraxial block)). 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 22 Jul 2021.