PregnancyNCT02159807
Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects
A study testing Bupivacaine and Fentanyl in people with Pregnancy, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Bupivacaine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2015to 29 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA (American Society of Anesthesiologists Physical status) 1-2 parturients at term requesting labor analgesia
- between 37 and 42 weeks gestational age
- maternal age of 18 years or greater
Who cannot join
- Parturients with pre-eclampsia
- History of pregnancy induced hypertension
- Patients in whom a spinal anesthetic is contraindicated (e.g. coagulopathy, local infection) or those in whom a CSE cannot be performed
- Patients with non reassuring fetal heart rate tracings prior to placement of the CSE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-blinded Study Designed to Optimize the Dose of Bupivacaine in Combined Spinal Epidurals to Reduce the Incidence of Fetal Bradycardia and Maternal Hypotension
The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.
Read the detailed description
A combined spinal epidural (CSE), which is the investigators' customary method of providing pain relief during your labor, is the identification of the epidural space in your lower back with a needle, followed by passing a thinner and longer needle through the first needle. This second needle will enter the patient's "spinal" (intrathecal) space by passing through the dura (thin covering separating the epidural space from the spinal space). The spinal (intrathecal) space is identified by flow of spinal fluid. The dura is the envelope around the spinal cord and the intrathecal space which is filled with spinal fluid. Medication will be injected at once into the spinal space, the thinner needle removed and a fine tube (catheter) will be threaded through the first needle into the epidural space. This catheter is in the epidural space and medication can be given through this catheter later on (hence the term combined) if needed. This study is a comparison of three different dosages (1.25mg, 1.66mg and 2.5 mg) of the local anesthetic (Bupivacaine) that we frequently use in the spinal, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), and of its effects on the patient's blood pressure (risk of maternal's drop of the blood pressure with possible bad effects on the blood flow to the baby), on the patient's baby's heart rate (risk of slowing down of the baby heart rate as a consequence of decreased blood flow to the baby), and the patient's pain relief (higher dose of medications are usually more effective for maternal pain relief but have side effects that can be bad for the mother and the baby). The doses of Bupivacaine the investigator routinely use on the labor and delivery floor go from 1.25 to 2.5 mg depending on clinician preferences. These doses are considered standard of care in the literature.
- Conditions
- Pregnancy
- Being tested
- Bupivacaine, Fentanyl
- Keywords
- Pain control, labor, epidural, pregnant
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Fentanyl
The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.
FentanylDrug
20 micrograms routinely administered in combination in the spinal anesthetic
| Study group | Role | What they receive |
|---|---|---|
| 1.25 mg Bupivacaine | Active comparator | 1.25mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic Receives: Drug: Bupivacaine; Drug: Fentanyl |
| 1.66 mg Bupivacaine | Active comparator | 1.66mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic Receives: Drug: Bupivacaine; Drug: Fentanyl |
| 2.5 mg Bupivacaine | Active comparator | 2.5mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic Receives: Drug: Bupivacaine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Blood Pressure
Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension
Measured: at 1 hour
Secondary outcomes (2)
Fetal Heart Rate at 1 Hour
Baby's heart rate recorded with the external monitor that is placed on patient's belly, for a duration of 60 minutes after the placement of the combined spinal epidural.
Measured: at 1 hour
Mean Change in Visual Analog Scale for Pain
Mean change of her pain relief from the spinal epidural 60 minutes after she received it, using a VAS, scored from 0 to 10, with higher score indicating more pain.
Measured: baseline and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study start24 Apr 2015
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PregnancyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Epstein, M.D., Principal investigator, Mount Sinai Roosevelt Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159807
- Sponsor's protocol ID
- GCO 13-0210
- Status last verified
- Dec 2018
- First submitted
- 6 Jun 2014
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blinded Study Designed to Optimize the Dose of Bupivacaine in Combined Spinal Epidurals to Reduce the Incidence of Fetal Bradycardia and Maternal Hypotension
- ClinicalTrials.gov ID
- NCT02159807
- Acronym / sponsor ID
- GCO 13-0210
- Conditions
- Pregnancy
- Keywords
- Pain control, labor, epidural, pregnant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- 24 Apr 2015 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor floor (depending on the physician preference) but the idea is to quantify safety, efficacy and side effects for each of these doses.
Detailed description
A combined spinal epidural (CSE), which is the investigators' customary method of providing pain relief during your labor, is the identification of the epidural space in your lower back with a needle, followed by passing a thinner and longer needle through the first needle. This second needle will enter the patient's "spinal" (intrathecal) space by passing through the dura (thin covering separating the epidural space from the spinal space). The spinal (intrathecal) space is identified by flow of spinal fluid. The dura is the envelope around the spinal cord and the intrathecal space which is filled with spinal fluid. Medication will be injected at once into the spinal space, the thinner needle removed and a fine tube (catheter) will be threaded through the first needle into the epidural space. This catheter is in the epidural space and medication can be given through this catheter later on (hence the term combined) if needed. This study is a comparison of three different dosages (1.25mg, 1.66mg and 2.5 mg) of the local anesthetic (Bupivacaine) that we frequently use in the spinal, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), and of its effects on the patient's blood pressure (risk of maternal's drop of the blood pressure with possible bad effects on the blood flow to the baby), on the patient's baby's heart rate (risk of slowing down of the baby heart rate as a consequence of decreased blood flow to the baby), and the patient's pain relief (higher dose of medications are usually more effective for maternal pain relief but have side effects that can be bad for the mother and the baby). The doses of Bupivacaine the investigator routinely use on the labor and delivery floor go from 1.25 to 2.5 mg depending on clinician preferences. These doses are considered standard of care in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.25 mg Bupivacaine | Active comparator | Drug: Bupivacaine, Drug: Fentanyl1.25mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic |
| 1.66 mg Bupivacaine | Active comparator | Drug: Bupivacaine, Drug: Fentanyl1.66mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic |
| 2.5 mg Bupivacaine | Active comparator | Drug: Bupivacaine, Drug: Fentanyl2.5mg of bupivacaine dose with 20 mcg of fentanyl was injected in the spinal portion of the anesthetic |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiologists Physical status) 1-2 parturients at term requesting labor analgesia
- between 37 and 42 weeks gestational age
- maternal age of 18 years or greater
Key exclusion criteria (4 listed)
- Parturients with pre-eclampsia
- History of pregnancy induced hypertension
- Patients in whom a spinal anesthetic is contraindicated (e.g. coagulopathy, local infection) or those in whom a CSE cannot be performed
- Patients with non reassuring fetal heart rate tracings prior to placement of the CSE
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 |
|---|---|---|
| BupivacaineAlso: FentanylThe dose of bupivacaine administered intrathecally during placement of the spinal anesthetic. | Drug | 1.25 mg Bupivacaine, 1.66 mg Bupivacaine, 2.5 mg Bupivacaine |
| Fentanyl20 micrograms routinely administered in combination in the spinal anesthetic | Drug | 1.25 mg Bupivacaine, 1.66 mg Bupivacaine, 2.5 mg Bupivacaine |
Primary outcome
Maternal Blood Pressure
Time frame: at 1 hour
Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension
2 secondary outcomes
Fetal Heart Rate at 1 Hour
Time frame: at 1 hour
Mean Change in Visual Analog Scale for Pain
Time frame: baseline and 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jonathan Epstein, M.D. principal investigator
Mount Sinai Roosevelt Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Fentanyl in people with Pregnancy, run by St. Luke's-Roosevelt Hospital Center 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jan 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maternal Blood Pressure (time frame: at 1 hour). 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 3 Jan 2019.