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COMPLETEDPhase 2NCT02020304

Combined Spinal-Epidural Temperature and Duration of Action

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 me...

Lead sponsor: Wake Forest University Health Sciences•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Wake Forest University Health Sciences

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.

Age

18 - 55 years

Sex

FEMALE

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 10, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment58

Start dateAug 2013

Last updatedSep 10, 2018

Condition

Locations shown

Forsyth Medical Center

Winston-Salem, North Carolina

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2018Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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