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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Labor Pain
Drug: Clonidine or fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Fentanyl-bupivacaine and Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor in Patients With Continuous Epidural Analgesia

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Completion Date: December 2011
Arms Assigned Interventions
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
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: 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691795

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Richard M Smiley, MD Professor of Clinical Anesthesiology, Columbia University
Principal Investigator: Imre Redai, MD Assistant Professor, Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00691795     History of Changes
Other Study ID Numbers: AAAC9826
Study First Received: June 3, 2008
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Analgesia
Epidural
Pregnancy
Labor
Clonidine
Fentanyl
Bupivacaine
Childbirth

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Fentanyl
Clonidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Adjuvants, Anesthesia
Narcotics

ClinicalTrials.gov processed this record on April 15, 2014