Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 48 |
| Updated: | 1/5/2019 |
| Start Date: | April 24, 2015 |
| End Date: | December 29, 2017 |
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.
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.
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.
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
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