Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Study Overview
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Brief Summary
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Terbutaline
* Drug: Fentanyl
* Drug: 0.9% NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Terbutaline<br>Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN | Drug: Terbutaline<br> <br> |
| Active Comparator: Fentanyl<br>Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN | Drug: Fentanyl<br> <br> |
| Placebo Comparator: Placebo<br>0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN | Drug: 0.9% NaCl<br> <br> * Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor Pain, Analgesia, Epidural