Combined Spinal-Epidural Temperature and Duration of Action

NCT ID: NCT02020304

Last Updated: 2018-09-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-29

Study Completion Date

2014-05-04

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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Room temperature

room temperature combined spinal epidural dose (60-75 degrees F)

Group Type EXPERIMENTAL

combined spinal epidural

Intervention Type DRUG

Combined Spinal Epidural

refrigerated temperature

refrigerated temperature combined spinal epidural dose (\~\<43 degrees F)

Group Type ACTIVE_COMPARATOR

combined spinal epidural

Intervention Type DRUG

Combined Spinal Epidural

Interventions

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combined spinal epidural

Combined Spinal Epidural

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vernon Ross, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 23933

Identifier Type: -

Identifier Source: org_study_id

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