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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Blood Pressure | Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension | at 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 1 hour |
| Mean Change in Visual Analog Scale for Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Epstein, M.D. | Mount Sinai Roosevelt Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roosevelt hospital | New York | New York | 10019 | United States |
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Enrollment period from April 2015 and completed Dec 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.25 mg Bupivacaine | 1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal |
| FG001 | 1.66 mg Bupivacaine | 1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal |
| FG002 | 2.5 mg Bupivacaine | 2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.25 mg Bupivacaine | 1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Blood Pressure | Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension | Posted | Mean | Standard Deviation | mm/Hg | at 1 hour |
|
60 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1.25 mg Bupivacaine | 1.25mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vasovagal response | Vascular disorders | SNOMED CT | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Orlando | Icahn School of Medicine at Mount Sinai | 917-496-7490 | barbara.orlando@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2014 | Nov 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Fentanyl | Drug | 20 micrograms routinely administered in combination in the spinal anesthetic |
|
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. |
| baseline and 60 minutes |
| elevated blood pressure |
|
| 1.66 mg Bupivacaine |
1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal |
| BG002 | 2.5 mg Bupivacaine | 2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Fetal Heart Rate (FHR) | Mean | Standard Deviation | beats per min |
|
| Pain Score | Pain Visual Analog Score is from 0-10, with higher score indicating more pain | Mean | Standard Deviation | units on a scale |
|
| OG002 | 2.5 mg Bupivacaine | 2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | beats per minute | at 1 hour |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline and 60 minutes |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | 1.66 mg Bupivacaine | 1.66mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | 2.5 mg Bupivacaine | 2.5mg, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), administered intrathecally during placement of the spinal anesthetic. Syringes will be prepared in advance by pharmacy. Twenty micrograms of fentanyl is routinely administered in combination with bupivacaine in the spinal | 0 | 48 | 0 | 48 | 1 | 48 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|