Combined Spinal-Epidural Temperature and Duration of Action

Study Overview
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Brief Summary
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The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.

Detailed Description
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Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator ( <43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.

Official Title
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Effect of Temperature of Combined Spinal Epidural Dosing on Duration

Conditions
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Pain

Intervention / Treatment
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* Drug: combined spinal epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 18 years of age not allergic to medications used to treat labor pain </= 6cm cervical dilation visual pain score >/=3 Exclusion Criteria: <18 years of age > 6 cm cervical dilation non-English speaking subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Room temperature<br>room temperature combined spinal epidural dose (60-75 degrees F) | Drug: combined spinal epidural<br>* Combined Spinal Epidural<br>|
| Active Comparator: refrigerated temperature<br>refrigerated temperature combined spinal epidural dose ( <43 degrees F) | Drug: combined spinal epidural<br>* Combined Spinal Epidural<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia ( 1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care. | up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia Onset-5 Minutes Post Injection |  | from time of CSE administration | 
| Analgesia Onset-10 Minutes Post Injection |  | up to 3 hours | 
| Analgesia Onset-15 Minutes Post Injection |  | up to 3 hours | 
| Pruritus | patients reporting pruritis at 30 minutes after CSE injection, self reported and measured on a scale of 0 (no itching at all) up to 10 (itching as bad as can be imagined) | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Combined spinal epidural duration, labor pain