Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Phase 4

• Conditions: Labor Pain
• Interventions: Drug: 0.9% NaCl; Drug: Fentanyl; Drug: Terbutaline

• Registration Number: NCT01651962
• Lead Sponsor: Kai Schoenhage

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-27
• Study Start: 2012-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-19
• Primary Completion: 2015-07
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	0.9% NaCl	0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
Fentanyl	Fentanyl	Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN
Terbutaline	Terbutaline	Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (2)

University of Arizona Medical Center; 🇺🇸 Tucson, Arizona, United States

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States