Clinical trial NCT00691795: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Labor Pain
Keywords: Analgesia
Epidural
Pregnancy
Labor
Clonidine
Fentanyl
Bupivacaine
Childbirth
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain score on a VAS scale (success = score less than or equal to 2 on a 10 point scale)
timeFrame: 15 minutes
Secondary outcomes:
measure: Maternal blood pressure
timeFrame: 2 hours
measure: Maternal heart rate
timeFrame: 2 hour
measure: Neonatal Apgar score
timeFrame: 1 and 5 minutes post delivery
measure: Mode of delivery (spontaneous vaginal versus instrumental vaginal versus cesarean
timeFrame: at delivery
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Professor of Clinical Anesthesiology, Columbia University
name: Richard M Smiley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor, Columbia University
name: Imre Redai, MD
role: PRINCIPAL_INVESTIGATOR
References: