- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651962
Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement
Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Kai Schoenhage, MD
- Phone Number: (520) 626-7221
- Email: kschoenhage@anesth.arizona.edu
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85712
- Recruiting
- Tucson Medical Center
-
Principal Investigator:
- Schoenhage Monique, M.D.
-
Tucson, Arizona, United States, 85724
- Recruiting
- University of Arizona Medical Center
-
Principal Investigator:
- Kai Schoenhage, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Terbutaline
Terbutaline 0.125mg i.v.
x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
|
|
Active Comparator: Fentanyl
Fentanyl 100mcg i.v.
x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
|
|
Placebo Comparator: Placebo
0.9% NaCl i.v.
x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0-30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0-30 minutes
|
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
|
0-30 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0-30 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Labor Pain
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Sympathomimetics
- Fentanyl
- Terbutaline
Other Study ID Numbers
- 12-0412
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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