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Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Arizona
Information provided by (Responsible Party):
Kai Schoenhage, University of Arizona Identifier:
First received: July 20, 2012
Last updated: May 20, 2014
Last verified: May 2014

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:

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 2014
Estimated Primary Completion Date: July 2014 (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


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

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 identifier: NCT01651962

Contact: Kai Schoenhage, MD (520) 626-7221

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
Principal Investigator: Kai Schoenhage, MD University of Arizona
  More Information

No publications provided

Responsible Party: Kai Schoenhage, Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology, University of Arizona Identifier: NCT01651962     History of Changes
Other Study ID Numbers: 12-0412
Study First Received: July 20, 2012
Last Updated: May 20, 2014
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
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents processed this record on November 25, 2014