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| Sponsor: | Columbia University |
|---|---|
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00691795 |
Purpose
Epidural analgesia is widely regarding as the most effective analgesic strategy for labor pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along with an opioid, e.g., our common "recipe" of 12 ml/hr of 0.0625% bupivacaine with 2 micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery. This dose of the infusion 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 breakthrough pain is treated 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 is often difficult to treat.
Although requests from patients to alleviate late stage breakthrough pain are common, no one knows 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 with an epidural infusion in place: clonidine-bupivacaine versus fentanyl-bupivacaine.
Women who have labor epidural analgesia in place will be enrolled to be randomized if and when they present with breakthrough pain in the late first stage or second stage of labor (≥ 8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75 micrograms of either fentanyl (an opioid or "narcotic") or clonidine (an "alpha-2 agonist known to be effective as an epidural analgesic).
Pain relief, labor progress and outcome will be assessed to compare fentanyl versus clonidine.
It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic than fentanyl added to bupivacaine for breakthrough pain in advanced labor.
| Condition | Intervention | Phase |
|---|---|---|
|
Labor Pain |
Drug: Clonidine or fentanyl |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of Fentanyl-Bupivacaine and Clonidine-Bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia |
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CLONIDINE: Experimental
Participants randomized to this arm of the study receive 75 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor
|
Drug: Clonidine or fentanyl
After obtaining consent, the patients will be randomized into two groups using a random allocation table. At the onset of late stage breakthrough pain one arm of patients will receive a mixture of 75 mcg clonidine and 10 mg bupivacaine in 8 ml of volume and the second group will receive 75 mcg fentanyl and 10 mg bupivacaine in 8 ml of volume.
|
|
FENTANYL: Experimental
Participants randomized to this arm of the study receive 75 micrograms fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor
|
Drug: Clonidine or fentanyl
After obtaining consent, the patients will be randomized into two groups using a random allocation table. At the onset of late stage breakthrough pain one arm of patients will receive a mixture of 75 mcg clonidine and 10 mg bupivacaine in 8 ml of volume and the second group will receive 75 mcg fentanyl and 10 mg bupivacaine in 8 ml of volume.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Richard M Smiley, MD | 212-305-5006 | rms7@columbia.edu |
| Contact: Imre Redai, MD | 212-305-6494 | ir71@columbia.edu |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Richard M Smiley, MD | Professor of Clinical Anesthesiology, Columbia University |
| Principal Investigator: | Imre Redai, MD | Assistant Professor, Columbia University |
More Information
| Responsible Party: | Columbia University ( Richard Smiley ) |
| Study ID Numbers: | AAAC9826 |
| Study First Received: | June 3, 2008 |
| Last Updated: | February 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00691795 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Analgesia Epidural Pregnancy Labor Clonidine |
Fentanyl Bupivacaine Pregnancy Childbirth |
|
Fentanyl Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Pain Adrenergic Agonists Signs and Symptoms Sensory System Agents Therapeutic Uses Analgesics Analgesics, Opioid Anesthetics, Intravenous Sympatholytics |
Adrenergic alpha-Agonists Clonidine Nervous System Diseases Central Nervous System Depressants Narcotics Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Anesthetics, Local Adjuvants, Anesthesia Anesthetics, General Autonomic Agents Labor Pain Neurologic Manifestations Bupivacaine |
