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Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Primary Purpose

Labor Pain

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Terbutaline
Fentanyl
0.9% NaCl
Sponsored by
Kai Schoenhage
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Labor Pain, Analgesia, Epidural

Eligibility Criteria

18 Years - 53 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tucson Medical CenterRecruiting
  • University of Arizona Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Terbutaline

Fentanyl

Placebo

Arm Description

Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

movement during epidural placement
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
semi-quantitative assessment of the subject's position during the epidural catheter placement: 0-1-2: excellent - moderate - poor

Full Information

First Posted
July 20, 2012
Last Updated
January 15, 2015
Sponsor
Kai Schoenhage
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1. Study Identification

Unique Protocol Identification Number
NCT01651962
Brief Title
Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement
Official Title
Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kai Schoenhage

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Labor Pain, Analgesia, Epidural

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Terbutaline
Arm Type
Experimental
Arm Description
Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
Intervention Type
Drug
Intervention Name(s)
Terbutaline
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl
Other Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
reduction of pain score on a visual analog scale (VAS) of 1-10
Description
semi-quantitative assessment of decrease in the subject's pain score after administration of the study drug for the placement of an epidural catheter
Time Frame
0-30 minutes
Secondary Outcome Measure Information:
Title
movement during epidural placement
Description
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
Time Frame
0-30 minutes
Title
position during epidural placement
Description
semi-quantitative assessment of the subject's position during the epidural catheter placement: 0-1-2: excellent - moderate - poor
Time Frame
0-30 minutes
Other Pre-specified Outcome Measures:
Title
hemodynamic and oxygenation assessment of parturient and fetus, side effects
Description
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
Time Frame
0-30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Schoenhage, MD
Phone
(520) 626-7221
Email
kschoenhage@anesth.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Schoenhage, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Schoenhage Monique, M.D.
Facility Name
University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Schoenhage, M.D.

12. IPD Sharing Statement

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Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

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