Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labor Pain
Intervention: Clonidine or Fentanyl (Drug); Clonidine or fentanyl (Drug); Clonidine or fentanyl (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Columbia University Official(s) and/or principal investigator(s): Allison Lee, MD, Principal Investigator, Affiliation: Columbia University
Overall contact: Allison Lee, MD, Email: al3196@columbia.edu
Summary
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 patient 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.
Clinical Details
Official title: Comparison of Fentanyl-bupivacaine and Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain Score on a VAS scale
Secondary outcome: Maternal blood pressureMaternal heart rate Neonatal Apgar score Number of spontaneous vaginal deliveries
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Allison Lee, MD, Email: al3196@columbia.edu
Columbia University Medical Center, New York, New York 10032, United States; Recruiting Allison Lee, MD Allison Lee, MD, Principal Investigator
Additional Information
Starting date: October 2013
Last updated: July 23, 2015
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