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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 3, 2008 | ||||||||
| Last Updated Date | February 2, 2009 | ||||||||
| Start Date ICMJE | March 2009 | ||||||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain score on a VAS scale (success = score less than or equal to 2 on a 10 point scale) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00691795 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Epidural Fentanyl-Bupivacaine Versus Clonidine-Bupivacaine for Breakthrough Pain in Advanced Labor | ||||||||
| Official Title ICMJE | Comparison of Fentanyl-Bupivacaine and Clonidine-Bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia | ||||||||
| Brief Summary | 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Labor Pain | ||||||||
| Intervention ICMJE | Drug: Clonidine or fentanyl | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | August 2011 | ||||||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00691795 | ||||||||
| Responsible Party | Richard Smiley, Columbia University | ||||||||
| Study ID Numbers ICMJE | AAAC9826 | ||||||||
| Study Sponsor ICMJE | Columbia University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Columbia University | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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