Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement
1 other identifier
interventional
250
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2012
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 19, 2015
January 1, 2015
2.9 years
July 20, 2012
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction of pain score on a visual analog scale (VAS) of 1-10
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 Outcomes (2)
movement during epidural placement
0-30 minutes
position during epidural placement
0-30 minutes
Other Outcomes (1)
hemodynamic and oxygenation assessment of parturient and fetus, side effects
0-30 minutes
Study Arms (3)
Terbutaline
EXPERIMENTALTerbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
Fentanyl
ACTIVE COMPARATORFentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
Placebo
PLACEBO COMPARATOR0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
Interventions
Eligibility Criteria
You may qualify if:
- in labor
- labor pain \>3 on visual analog scale (VAS)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kai Schoenhagelead
Study Sites (2)
Tucson Medical Center
Tucson, Arizona, 85712, United States
University of Arizona Medical Center
Tucson, Arizona, 85724, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kai Schoenhage, MD
University of Arizona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology
Study Record Dates
First Submitted
July 20, 2012
First Posted
July 27, 2012
Study Start
August 1, 2012
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
January 19, 2015
Record last verified: 2015-01