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

NCT00691795 | Withdrawn Phase 4

• 1 other identifier: AAAC9826
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Analgesia; Epidural; Pregnancy; Labor; Clonidine; Fentanyl; Bupivacaine; Childbirth

Outcome Measures

Primary Outcomes (1)

• Pain score on a VAS scale (success = score less than or equal to 2 on a 10 point scale)

  15 minutes

Secondary Outcomes (4)

• Maternal blood pressure

  2 hours

• Maternal heart rate

  2 hour

• Neonatal Apgar score

  1 and 5 minutes post delivery

• Mode of delivery (spontaneous vaginal versus instrumental vaginal versus cesarean

  at delivery

Study Arms (2)

CLONIDINE

EXPERIMENTAL

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

FENTANYL

EXPERIMENTAL

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

Interventions

Clonidine or fentanyl DRUG

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.

Also known as: Clonidine = "DuraClon", Fentanyl= fentanyl = Sublimaze

CLONIDINE; FENTANYL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women in labor at term pregnancy
• healthy
• epidural analgesia in place
• breakthrough pain in advanced labor

You may not qualify if:

• chronic pain syndrome
• receiving systemic opioids within 4 hours
• receiving chronic antidepressants, clonidine, opioids

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Clonidine; Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Richard M Smiley, MD

  Professor of Clinical Anesthesiology, Columbia University

  PRINCIPAL INVESTIGATOR

• Imre Redai, MD

  Assistant Professor, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Completion: December 1, 2011
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)