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Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Sponsor
Kai Schoenhage (Other)
Overall Status
Unknown status
CT.gov ID
NCT01651962
Collaborator
(none)
250
Enrollment
2
Locations
3
Arms
40
Duration (Months)
125
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain
Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Jul 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • normal saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. reduction of pain score on a visual analog scale (VAS) of 1-10 [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

    Secondary Outcome Measures

    1. movement during epidural placement [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

    2. position during epidural placement [0-30 minutes]

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

    Other Outcome Measures

    1. hemodynamic and oxygenation assessment of parturient and fetus, side effects [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 53 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Tucson Medical Center Tucson Arizona United States 85712
    2 University of Arizona Medical Center Tucson Arizona United States 85724

    Sponsors and Collaborators

    • Kai Schoenhage

    Investigators

    • Principal Investigator: Kai Schoenhage, MD, University of Arizona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kai Schoenhage, Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology, University of Arizona
    ClinicalTrials.gov Identifier:
    NCT01651962
    Other Study ID Numbers:
    • 12-0412
    First Posted:
    Jul 27, 2012
    Last Update Posted:
    Jan 19, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Kai Schoenhage, Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology, University of Arizona
    Labor Pain
    Analgesia, Epidural
    Additional relevant MeSH terms:
    Labor Pain
    Fentanyl
    Terbutaline

    Study Results

    No Results Posted as of Jan 19, 2015