Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

January 15, 2015 updated by: Kai Schoenhage

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

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • normal saline

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

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

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.

Clinical Trials on Labor Pain

Clinical Trials on Fentanyl

Subscribe