Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2015 by University of Arizona

Sponsor:

Information provided by (Responsible Party):

Kai Schoenhage, University of Arizona

ClinicalTrials.gov Identifier:

NCT01651962

First received: July 20, 2012

Last updated: January 15, 2015

Last verified: January 2015

History of Changes

Purpose

Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.

Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.

This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.

Condition	Intervention	Phase
Labor Pain	Drug: Terbutaline Drug: Fentanyl Drug: 0.9% NaCl	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:	Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain

Resource links provided by NLM:

Drug Information available for: Fentanyl Fentanyl citrate Terbutaline Terbutaline sulfate

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:

reduction of pain score on a visual analog scale (VAS) of 1-10 [ Time Frame: 0-30 minutes ] [ Designated as safety issue: No ]
semi-quantitative assessment of decrease in the subject's pain score after administration of the study drug for the placement of an epidural catheter

Secondary Outcome Measures:

movement during epidural placement [ Time Frame: 0-30 minutes ] [ Designated as safety issue: No ]
semi-quantitative assessment of the subject's movement during placement of the epidural catheter: 0-1-2-3: none - extremities - trunk a bit - trunk a lot
position during epidural placement [ Time Frame: 0-30 minutes ] [ Designated as safety issue: No ]
semi-quantitative assessment of the subject's position during the epidural catheter placement: 0-1-2: excellent - moderate - poor

Other Outcome Measures:

hemodynamic and oxygenation assessment of parturient and fetus, side effects [ Time Frame: 0-30 minutes ] [ Designated as safety issue: Yes ]
heart rate (HR), non-invasive blood pressure (NIBP), pulse-oximetry (SpO2), fetal heart rate (FHR), uterine contractions (CTG - cardiotocogram); feeling of being jittery, pruritus and nausea


Estimated Enrollment:	250
Study Start Date:	August 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Terbutaline Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN	Drug: Terbutaline
Active Comparator: Fentanyl Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN	Drug: Fentanyl
Placebo Comparator: Placebo 0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN	Drug: 0.9% NaCl Other Name: normal saline

Eligibility


Ages Eligible for Study:	18 Years to 53 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

in labor
labor pain >3 on visual analog scale (VAS)

Exclusion Criteria:

cardiovascular disease
preeclampsia
diabetes mel-litus
thyroid disease
current (outpatient) opioid medication
recent and / or current use of cocaine
seizure disorder
psychiatric disease
body mass index >35
preterm labor (<37 weeks pregnant)
known allergies to any of the three study substances

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651962

Contacts


Contact: Kai Schoenhage, MD	(520) 626-7221	kschoenhage@anesth.arizona.edu

Locations


United States, Arizona
Tucson Medical Center	Recruiting
Tucson, Arizona, United States, 85712
Principal Investigator: Schoenhage Monique, M.D.
University of Arizona Medical Center	Recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Kai Schoenhage, M.D.

Sponsors and Collaborators

Kai Schoenhage

Investigators


Principal Investigator:	Kai Schoenhage, MD	University of Arizona

More Information


Responsible Party:	Kai Schoenhage, Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology, University of Arizona
ClinicalTrials.gov Identifier:	NCT01651962 History of Changes
Other Study ID Numbers:	12-0412
Study First Received:	July 20, 2012
Last Updated:	January 15, 2015
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by University of Arizona:


Labor Pain Analgesia, Epidural

Additional relevant MeSH terms:


Labor Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Fentanyl Terbutaline Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia	Anesthetics, Intravenous Anesthetics, General Anesthetics Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents Sympathomimetics Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 30, 2016

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