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Combined Spinal-Epidural Temperature and Duration of Action

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ClinicalTrials.gov Identifier: NCT02020304
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : August 24, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: combined spinal epidural Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Effect of Temperature of Combined Spinal Epidural Dosing on Duration
Actual Study Start Date : August 29, 2013
Actual Primary Completion Date : May 4, 2014
Actual Study Completion Date : May 4, 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Room temperature
room temperature combined spinal epidural dose (60-75 degrees F)
 Drug: combined spinal epidural
Combined Spinal Epidural
Active Comparator: refrigerated temperature
refrigerated temperature combined spinal epidural dose (~<43 degrees F)
 Drug: combined spinal epidural
Combined Spinal Epidural


Outcome Measures
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Primary Outcome Measures :
  1. Time [ Time Frame: 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 :
  1. Analgesia Onset-5 Minutes Post Injection [ Time Frame: from time of CSE administration ]
  2. Analgesia Onset-10 Minutes Post Injection [ Time Frame: up to 3 hours ]
  3. Analgesia Onset-15 Minutes Post Injection [ Time Frame: up to 3 hours ]
  4. Pruritus [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020304


Locations
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United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Vernon Ross, MD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02020304    
Other Study ID Numbers: IRB 23933
First Posted: December 24, 2013    Key Record Dates
Results First Posted: August 24, 2017
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Combined spinal epidural duration
labor pain