Combined Spinal-Epidural Temperature and Duration of Action

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: combined spinal epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT02020304

IRB 23933

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Room temperature

Experimental group

Description:

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

Treatment:

Drug: combined spinal epidural

refrigerated temperature

Active Comparator group

Description:

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

Treatment:

Drug: combined spinal epidural