Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2018 |
| Start Date: | July 15, 2014 |
| End Date: | January 20, 2017 |
Comparison of Fentanyl-bupivacaine and Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia
Epidural analgesia has proven to be an effective method for severe pain relief associated
with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and
narcotic will be administered through an epidural catheter. As labor progresses and the
baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs
further treatment. The investigators provide pain relief by administering analgesics through
the epidural catheter. The patients will be randomly assigned to receive one of two
medication mixtures believed to be successful in treating this type of pain associated with
advanced labor. After this initial treatment, if pain relief is not attained, the patient may
receive the other medication as well. The medications used in this study have been used at
this institution for some time and have been found to be safe for mother and baby. The opioid
(fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other
medication (clonidine) better known as a blood pressure medication has also been used for
pain relief. Studies and clinical experience have shown that clonidine when given epidurally
in the doses used in this study has minimal, if any effect, on the blood pressure of the
mother or of the baby. The investigators will record medical and obstetric history and labor
progress relevant to the patient. The patient will be asked questions regarding labor pain
and side effects before and after the analgesic is administered. The primary objective is to
determine which treatment regimen is more successful in abolishing breakthrough pain in
advanced labor.
with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and
narcotic will be administered through an epidural catheter. As labor progresses and the
baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs
further treatment. The investigators provide pain relief by administering analgesics through
the epidural catheter. The patients will be randomly assigned to receive one of two
medication mixtures believed to be successful in treating this type of pain associated with
advanced labor. After this initial treatment, if pain relief is not attained, the patient may
receive the other medication as well. The medications used in this study have been used at
this institution for some time and have been found to be safe for mother and baby. The opioid
(fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other
medication (clonidine) better known as a blood pressure medication has also been used for
pain relief. Studies and clinical experience have shown that clonidine when given epidurally
in the doses used in this study has minimal, if any effect, on the blood pressure of the
mother or of the baby. The investigators will record medical and obstetric history and labor
progress relevant to the patient. The patient will be asked questions regarding labor pain
and side effects before and after the analgesic is administered. The primary objective is to
determine which treatment regimen is more successful in abolishing breakthrough pain in
advanced labor.
Epidural analgesia is a popular choice among patients for relief of severe pain associated
with labor and delivery. Currently, at the investigators' institution the investigators use a
continuous infusion of low dose local anesthetic and narcotic (12 ml/hr of 0.0625%
bupivacaine with 2 micrograms/ml fentanyl) after the initial spinal or epidural dose to
maintain patient comfort until delivery. This dose of the infusion is chosen because it often
provides adequate comfort without interfering with the mobility of the patient and her
ability to effectively push during delivery. However, this low-dose epidural infusion
strategy often results in recurrence of pain after an initial pain-free period. This
recurring pain is known as breakthrough pain and is alleviated by administering small boluses
of analgesics via the epidural catheter.
The pain occurring in labor is initially of visceral origin and is mediated by pain fibers
originating from the low thoracic and upper lumbar segments of the spinal cord. As labor
progresses to the late first phase (also known as transitional stage), pain sensations
originating from the distension of the pelvic floor, vagina and perineum adds a somatic
component to labor pain. This type of breakthrough pain, mediated by nerve fibers originating
from the sacral nerves at dermatomes S2-S4, is often difficult to treat. Patients may
experience inadequate analgesia even after boluses of analgesics are administered. Inadequate
analgesia is deleterious due to subjective discomfort with its associated neurohumoral and
physiological changes, and can be an initiator of the urge to bear down (push). Pushing
before complete dilation of the cervix may lead to swelling, cervical injury and premature
exhaustion of the mother. Adequate pain control will allow the cervix to fully dilate and
motivate the mother to push effectively at the appropriate time. Although requests from
patients to alleviate late stage breakthrough pain are common, there are no established data
in the literature regarding the most effective strategy for pain management in this stage of
labor.
This study is designed to compare the efficacy of two treatments for controlling late first
stage breakthrough pain during labor: clonidine-bupivacaine versus fentanyl-bupivacaine. Both
strategies are used at Columbia University Medical Center (CUMC) in this clinical situation,
and there is no clear evidence whether one is superior.
with labor and delivery. Currently, at the investigators' institution the investigators use a
continuous infusion of low dose local anesthetic and narcotic (12 ml/hr of 0.0625%
bupivacaine with 2 micrograms/ml fentanyl) after the initial spinal or epidural dose to
maintain patient comfort until delivery. This dose of the infusion is chosen because it often
provides adequate comfort without interfering with the mobility of the patient and her
ability to effectively push during delivery. However, this low-dose epidural infusion
strategy often results in recurrence of pain after an initial pain-free period. This
recurring pain is known as breakthrough pain and is alleviated by administering small boluses
of analgesics via the epidural catheter.
The pain occurring in labor is initially of visceral origin and is mediated by pain fibers
originating from the low thoracic and upper lumbar segments of the spinal cord. As labor
progresses to the late first phase (also known as transitional stage), pain sensations
originating from the distension of the pelvic floor, vagina and perineum adds a somatic
component to labor pain. This type of breakthrough pain, mediated by nerve fibers originating
from the sacral nerves at dermatomes S2-S4, is often difficult to treat. Patients may
experience inadequate analgesia even after boluses of analgesics are administered. Inadequate
analgesia is deleterious due to subjective discomfort with its associated neurohumoral and
physiological changes, and can be an initiator of the urge to bear down (push). Pushing
before complete dilation of the cervix may lead to swelling, cervical injury and premature
exhaustion of the mother. Adequate pain control will allow the cervix to fully dilate and
motivate the mother to push effectively at the appropriate time. Although requests from
patients to alleviate late stage breakthrough pain are common, there are no established data
in the literature regarding the most effective strategy for pain management in this stage of
labor.
This study is designed to compare the efficacy of two treatments for controlling late first
stage breakthrough pain during labor: clonidine-bupivacaine versus fentanyl-bupivacaine. Both
strategies are used at Columbia University Medical Center (CUMC) in this clinical situation,
and there is no clear evidence whether one is superior.
Inclusion Criteria:
- women in labor at term pregnancy
- healthy
- epidural analgesia in place
- breakthrough pain in advanced labor
Exclusion Criteria:
- chronic pain syndrome
- receiving systemic opioids within 4 hours
- receiving chronic antidepressants, clonidine, opioids
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Allison Lee, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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