Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor

This study has been withdrawn prior to enrollment.
(Study was recently terminated due to poor enrollment - never enrolled.)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00691795
First received: June 3, 2008
Last updated: February 13, 2012
Last verified: February 2012

June 3, 2008
February 13, 2012
Not Provided
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00691795 on ClinicalTrials.gov Archive Site
  • Maternal blood pressure [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
  • Maternal heart rate [ Time Frame: 2 hour ] [ Designated as safety issue: Yes ]
  • Neonatal Apgar score [ Time Frame: 1 and 5 minutes post delivery ] [ Designated as safety issue: Yes ]
  • Mode of delivery (spontaneous vaginal versus instrumental vaginal versus cesarean [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Labor Pain
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.
Other Names:
  • Clonidine = "DuraClon"
  • Fentanyl= fentanyl = Sublimaze
  • Experimental: CLONIDINE
    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
    Intervention: Drug: Clonidine or fentanyl
  • Experimental: FENTANYL
    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
    Intervention: Drug: Clonidine or fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2011
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00691795
AAAC9826
No
Columbia University
Columbia University
Not Provided
Principal Investigator: Richard M Smiley, MD Professor of Clinical Anesthesiology, Columbia University
Principal Investigator: Imre Redai, MD Assistant Professor, Columbia University
Columbia University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP