Pregnancy
Conditions
Keywords
Pain control, labor, epidural, pregnant
Brief 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. 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.
Interventions
DRUGBupivacaine
The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.
DRUGFentanyl
20 micrograms routinely administered in combination in the spinal anesthetic
Sponsors
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Blood Pressure | at 1 hour | Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Rate at 1 Hour | 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. |
| Mean Change in Visual Analog Scale for Pain | baseline and 60 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment period from April 2015 and completed Dec 2017
Participants by arm
| Arm | Count |
|---|---|
| 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 | 66 |
| 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 | 51 |
| 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 | 48 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | elevated blood pressure | 0 | 0 | 1 |
| Overall Study | No CSF | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | 1.25 mg Bupivacaine | 1.66 mg Bupivacaine | 2.5 mg Bupivacaine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 51 Participants | 48 Participants | 165 Participants |
| Fetal Heart Rate (FHR) | 141.13 beats per min STANDARD_DEVIATION 12.34 | 136.08 beats per min STANDARD_DEVIATION 9.8 | 135.23 beats per min STANDARD_DEVIATION 9.57 | 137.48 beats per min STANDARD_DEVIATION 10.57 |
| Pain Score | 8.15 units on a scale STANDARD_DEVIATION 2.27 | 8.24 units on a scale STANDARD_DEVIATION 1.61 | 8.61 units on a scale STANDARD_DEVIATION 1.51 | 8.33 units on a scale STANDARD_DEVIATION 1.79 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 66 Participants | 51 Participants | 48 Participants | 165 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 51 | 0 / 48 |
| other Total, other adverse events | 0 / 66 | 0 / 51 | 1 / 48 |
| serious Total, serious adverse events | 0 / 66 | 0 / 51 | 0 / 48 |
Outcome results
Primary
Maternal Blood Pressure
Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension
Time frame: at 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.25 mg Bupivacaine | Maternal Blood Pressure | 78.2 mm/Hg | Standard Deviation 8.17 |
| 1.66 mg Bupivacaine | Maternal Blood Pressure | 79.58 mm/Hg | Standard Deviation 9.25 |
| 2.5 mg Bupivacaine | Maternal Blood Pressure | 80.52 mm/Hg | Standard Deviation 8.51 |
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.
Time frame: at 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.25 mg Bupivacaine | Fetal Heart Rate at 1 Hour | 134.73 beats per minute | Standard Deviation 10.87 |
| 1.66 mg Bupivacaine | Fetal Heart Rate at 1 Hour | 137.64 beats per minute | Standard Deviation 10.35 |
| 2.5 mg Bupivacaine | Fetal Heart Rate at 1 Hour | 135.57 beats per minute | Standard Deviation 10.07 |
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.
Time frame: baseline and 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1.25 mg Bupivacaine | Mean Change in Visual Analog Scale for Pain | 0.43 score on a scale | Standard Deviation 1.13 |
| 1.66 mg Bupivacaine | Mean Change in Visual Analog Scale for Pain | 0.46 score on a scale | Standard Deviation 1.28 |
| 2.5 mg Bupivacaine | Mean Change in Visual Analog Scale for Pain | 0.26 score on a scale | Standard Deviation 1.07 |