Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Kai Schoenhage, University of Arizona
ClinicalTrials.gov Identifier:
NCT01651962
First received: July 20, 2012
Last updated: May 20, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651962

Contacts
Contact: Kai Schoenhage, MD (520) 626-7221 kschoenhage@anesth.arizona.edu

Locations
United States, Arizona
University of Arizona Medical Center Recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Kai Schoenhage, M.D.         
Tucson Medical Center Recruiting
Tucson, Arizona, United States, 85712
Principal Investigator: Schoenhage Monique, M.D.         
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, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology, University of Arizona
ClinicalTrials.gov Identifier: NCT01651962     History of Changes
Other Study ID Numbers: 12-0412
Study First Received: July 20, 2012
Last Updated: May 20, 2014
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
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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 October 01, 2014