Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain

NCT01846221 | Completed Phase 4 Results FDA Drug

• 1 other identifier: AAAL4101
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural analgesia has proven to be an effective method for severe pain relief associated with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and narcotic will be administered through an epidural catheter. As labor progresses and the baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs further treatment. The investigators provide pain relief by administering analgesics through the epidural catheter. The patients will be randomly assigned to receive one of two medication mixtures believed to be successful in treating this type of pain associated with advanced labor. After this initial treatment, if pain relief is not attained, the patient may receive the other medication as well. The medications used in this study have been used at this institution for some time and have been found to be safe for mother and baby. The opioid (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other medication (clonidine) better known as a blood pressure medication has also been used for pain relief. Studies and clinical experience have shown that clonidine when given epidurally in the doses used in this study has minimal, if any effect, on the blood pressure of the mother or of the baby. The investigators will record medical and obstetric history and labor progress relevant to the patient. The patient will be asked questions regarding labor pain and side effects before and after the analgesic is administered. The primary objective is to determine which treatment regimen is more successful in abolishing breakthrough pain in advanced labor.

Conditions

Labor Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Success Rate at 15 Minutes Post-epidural Bolus Injection

  Pain Visual Analogue Scale (VAS) was evaluated every 5 min for 15 min. 'Success' is defined as at least a 4-point reduction in VAS at 15 min. (0=no pain, 10= worst pain)

  Baseline, 15 Minutes post epidural administration

Secondary Outcomes (4)

• Maternal Systolic Blood Pressure

  Baseline, 30 Minutes post epidural administration

• Maternal Heart Rate

  Baseline, 30 Minutes post epidural administration

• Neonatal Apgar Score

  1 minute and 5 minutes post delivery

• Number of Spontaneous Vaginal Deliveries

  Upon delivery (approximately up to 8 hours from baseline)

Study Arms (2)

Clonidine

EXPERIMENTAL

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Drug: Clonidine

Fentanyl

EXPERIMENTAL

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Drug: Fentanyl

Interventions

Clonidine DRUG

Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Also known as: DuraClon

Clonidine

Fentanyl DRUG

Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

Also known as: Sublimaze

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

Related Links

• The Journal of the American Society of Anesthesiologists Abstract

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

Results Point of Contact

• Title: Allison Lee, MD - Assistant Professor of Anesthesiology
• Organization: Columbia University

al3196@cumc.columbia.edu

212-342-2028

Study Officials

• Allison Lee, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group assignment will be performed by opening a previously prepared numbered opaque envelope containing the assignment "CLO" or "FENT". The investigator preparing the study drug will not reveal the group assignment. The investigator administering the drug (different from the investigator preparing the drug) and assessing the outcomes will be blinded to the group assignment. The participant will also be blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Anesthesiology

Model Details: Subjects will randomly receive either a mixture of 100 mcg of clonidine and 12.5 mg of bupivacaine for a total volume of 10 ml ("CLON" group) and the other group will receive 100 mcg of fentanyl and 12.5 mg of bupivacaine for a total volume of 10 ml ("FENT" group). If the treatment is declared a failure, the patient will receive the alternative of the initial treatment.

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: July 15, 2014
• Primary Completion: January 20, 2017
• Study Completion: January 20, 2017
• Last Updated: May 3, 2018
• Results First Posted: May 3, 2018

Record last verified: 2018-04

Locations

US (1)