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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Room temperature | Experimental | room temperature combined spinal epidural dose (60-75 degrees F) |
|
| refrigerated temperature | Active Comparator | refrigerated temperature combined spinal epidural dose (~<43 degrees F) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined spinal epidural | Drug | Combined Spinal Epidural |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vernon Ross, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Room Temperature | room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural |
| FG001 | Refrigerated Temperature | refrigerated temperature combined spinal epidural dose (~<43 degrees F) combined spinal epidural: Combined Spinal Epidural |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Room Temperature | room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural |
| BG001 | Refrigerated Temperature | refrigerated temperature combined spinal epidural dose (~<43 degrees F) combined spinal epidural: Combined Spinal Epidural |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | up to 3 hours |
|
up to 3 hours after dosing
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Room Temperature | room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vernon H Ross MD | Wake Forest School of Medicine | 336-718-8278 | vhross@wakehealth.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Analgesia Onset-5 Minutes Post Injection | number of subjects who achieved a VAS pain score of \ | Posted | Count of Participants | Participants | No | from time of CSE administration |
|
|
|
| Secondary | Analgesia Onset-10 Minutes Post Injection | number of subjects who achieved a VAS pain score of \ | Posted | Count of Participants | Participants | up to 3 hours |
|
|
|
| Secondary | Analgesia Onset-15 Minutes Post Injection | number of subjects who achieved a VAS pain score of \ | Posted | Count of Participants | Participants | up to 3 hours |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Refrigerated Temperature | refrigerated temperature combined spinal epidural dose (~<43 degrees F) combined spinal epidural: Combined Spinal Epidural | 0 | 26 | 0 | 26 | 0 | 26 |
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