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Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

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ClinicalTrials.gov Identifier: NCT01651962
Recruitment Status : Unknown
Verified January 2015 by Kai Schoenhage, University of Arizona.
Recruitment status was:  Recruiting
First Posted : July 27, 2012
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Kai Schoenhage, University of Arizona

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Labor Pain Drug: Terbutaline Drug: Fentanyl Drug: 0.9% NaCl Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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
Study Start Date : August 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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:
  1. 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


Eligibility Criteria
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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
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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
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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 Posted: July 27, 2012    Key Record Dates
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