Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Labor Pain Clinical Trial

Official title:

Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01651962
• Other study ID #: 12-0412
• Status: Recruiting
• Phase: Phase 4
• First received: July 20, 2012
• Last updated: January 15, 2015
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: University of Arizona
• Contact: Kai Schoenhage, MD
• Phone: (520) 626-7221
• Email: kschoenhage[@]anesth.arizona.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 53 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Terbutaline

• Fentanyl

• 0.9% NaCl

Locations

Country	Name	City	State
United States	Tucson Medical Center	Tucson	Arizona
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Kai Schoenhage

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hemodynamic and oxygenation assessment of parturient and fetus, side effects	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	Yes
Primary	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	No
Secondary	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	0-30 minutes	No
Secondary	position during epidural placement	semi-quantitative assessment of the subject's position during the epidural catheter placement: 0-1-2: excellent - moderate - poor	0-30 minutes	No