Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor
|ClinicalTrials.gov Identifier: NCT00691795|
Recruitment Status : Withdrawn (Study was recently terminated due to poor enrollment - never enrolled.)
First Posted : June 5, 2008
Last Update Posted : February 14, 2012
|First Submitted Date ICMJE||June 3, 2008|
|First Posted Date ICMJE||June 5, 2008|
|Last Update Posted Date||February 14, 2012|
|Study Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|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 ]|
|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
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|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|
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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Condition ICMJE||Labor Pain|
|Intervention ICMJE||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.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date||December 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00691795|
|Other Study ID Numbers ICMJE||AAAC9826|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Columbia University|
|Study Sponsor ICMJE||Columbia University|
|Collaborators ICMJE||Not Provided|
|PRS Account||Columbia University|
|Verification Date||February 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP