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Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2015 by Kai Schoenhage, University of Arizona.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01651962

First Posted: July 27, 2012

Last Update Posted: January 19, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Kai Schoenhage, University of Arizona

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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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 Terbutaline Terbutaline sulfate

U.S. FDA Resources

Further study details as provided by Kai Schoenhage, University of Arizona:

Primary Outcome Measures:

reduction of pain score on a visual analog scale (VAS) of 1-10 [ Time Frame: 0-30 minutes ]
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 ]
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 ]
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 ]
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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 53 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	July 20, 2012
First Posted:	July 27, 2012
Last Update Posted:	January 19, 2015
Last Verified:	January 2015

Keywords provided by Kai Schoenhage, 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

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