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Completed

NCT Number: NCT02020304

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 medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.

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Key information

Conditions

Pain Labor Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined spinal epidural

Drug

Combined Spinal Epidural

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Effect of Temperature of Combined Spinal Epidural Dosing on Duration

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2013
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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