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
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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 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 |

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

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

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
Contact: Kai Schoenhage, MD | (520) 626-7221 | kschoenhage@anesth.arizona.edu |
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. |
Principal Investigator: | Kai Schoenhage, MD | University of Arizona |
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 |
Other Study ID Numbers: |
12-0412 |
First Posted: | July 27, 2012 Key Record Dates |
Last Update Posted: | January 19, 2015 |
Last Verified: | January 2015 |
Labor Pain Analgesia, Epidural |
Labor Pain Pain Neurologic Manifestations 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 Molecular Mechanisms of Pharmacological Action |