Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement
This study is not yet open for participant recruitment.
Verified July 2012 by University of Arizona
Sponsor:
Kai Schoenhage
Information provided by (Responsible Party):
Kai Schoenhage, University of Arizona
ClinicalTrials.gov Identifier:
NCT01651962
First received: July 20, 2012
Last updated: July 24, 2012
Last verified: July 2012
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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 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 53 Years |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651962
Contacts
| Contact: Kai Schoenhage, MD | (520) 626-7221 | kaischo@email.arizona.edu |
Locations
| United States, Arizona | |
| University of Arizona Medical Center | Not yet recruiting |
| Tucson, Arizona, United States, 85724 | |
| Principal Investigator: Kai Schoenhage, MD | |
Sponsors and Collaborators
Kai Schoenhage
Investigators
| Principal Investigator: | Kai Schoenhage, MD | University of Arizona |
More Information
No publications provided
| Responsible Party: | Kai Schoenhage, Assistant Professor, Director of Liver Transplant Anesthesia, Department of Anesthesiology, University of Arizona |
| ClinicalTrials.gov Identifier: | NCT01651962 History of Changes |
| Other Study ID Numbers: | 12-0412-01 |
| Study First Received: | July 20, 2012 |
| Last Updated: | July 24, 2012 |
| 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 Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Fentanyl Terbutaline Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics |
Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents Sympathomimetics Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
ClinicalTrials.gov processed this record on May 23, 2013