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

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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
• 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

Primary Measures

• Pain score on a VAS scale (success = score less than or equal to 2 on a 10 point scale)
  • Time Frame: 15 minutes
    Safety Issue?: No

Secondary Measures

• Maternal blood pressure
  • Time Frame: 2 hours
    Safety Issue?: Yes
• Maternal heart rate
  • Time Frame: 2 hour
    Safety Issue?: Yes
• Neonatal Apgar score
  • Time Frame: 1 and 5 minutes post delivery
    Safety Issue?: Yes
• Mode of delivery (spontaneous vaginal versus instrumental vaginal versus cesarean
  • Time Frame: at delivery
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Columbia University Other

Overall Clinical Trial Officials and Contacts

Richard M Smiley, MD Principal Investigator Professor of Clinical Anesthesiology, Columbia University  

Overall Contact: Richard M Smiley, MD 212-305-5006 rms7@columbia.edu

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00691795

Study ID Number: AAAC9826

ClinicalTrials.gov Identifier: NCT00691795

Health Authority: United States: Institutional Review Board