Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
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|ClinicalTrials.gov Identifier: NCT01846221|
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : May 3, 2018
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Labor Pain||Drug: Clonidine Drug: Fentanyl||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will randomly receive either a mixture of 100 mcg of clonidine and 12.5 mg of bupivacaine for a total volume of 10 ml ("CLON" group) and the other group will receive 100 mcg of fentanyl and 12.5 mg of bupivacaine for a total volume of 10 ml ("FENT" group). If the treatment is declared a failure, the patient will receive the alternative of the initial treatment.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Group assignment will be performed by opening a previously prepared numbered opaque envelope containing the assignment "CLO" or "FENT". The investigator preparing the study drug will not reveal the group assignment. The investigator administering the drug (different from the investigator preparing the drug) and assessing the outcomes will be blinded to the group assignment. The participant will also be blinded to the group assignment.|
|Official Title:||Comparison of Fentanyl-bupivacaine and Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia|
|Actual Study Start Date :||July 15, 2014|
|Actual Primary Completion Date :||January 20, 2017|
|Actual Study Completion Date :||January 20, 2017|
Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
Other Name: DuraClon
Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
Other Name: Sublimaze
- Number of Subjects With Success Rate at 15 Minutes Post-epidural Bolus Injection [ Time Frame: Baseline, 15 Minutes post epidural administration ]Pain Visual Analogue Scale (VAS) was evaluated every 5 min for 15 min. 'Success' is defined as at least a 4-point reduction in VAS at 15 min. (0=no pain, 10= worst pain)
- Maternal Systolic Blood Pressure [ Time Frame: Baseline, 30 Minutes post epidural administration ]Blood pressure will be measured at different timepoints.
- Maternal Heart Rate [ Time Frame: Baseline, 30 Minutes post epidural administration ]Heart rate will be measured at different timepoints.
- Neonatal Apgar Score [ Time Frame: 1 minute and 5 minutes post delivery ]The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
- Number of Spontaneous Vaginal Deliveries [ Time Frame: Upon delivery (approximately up to 8 hours from baseline) ]Mode of delivery: spontaneous vaginal or instrumental vaginal versus cesarean.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846221
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Allison Lee, MD||Columbia University|