Combined Spinal-Epidural Temperature and Duration of Action

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: combined spinal epidural

• Registration Number: NCT02020304
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08-29
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Primary Completion: 2014-05-04
• Study Completion: 2014-05-04
• Results First Submitted: 2017-07-25
• Results First Submitted QC: 2017-07-25
• Results First Posted: 2017-08-24
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

Inclusion Criteria

• >/= 18 years of age not allergic to medications used to treat labor pain </= 6cm cervical dilation visual pain score >/=3

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Exclusion Criteria

• <18 years of age > 6 cm cervical dilation non-English speaking subjects

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Room temperature	combined spinal epidural	room temperature combined spinal epidural dose (60-75 degrees F)
refrigerated temperature	combined spinal epidural	refrigerated temperature combined spinal epidural dose (\~\<43 degrees F)

Primary Outcome Measures

Name	Time	Method
Time	up to 3 hours	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.

Secondary Outcome Measures

Name	Time	Method
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	30 minutes	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)

Trial Locations

Locations (1)

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States