Combined Spinal-Epidural Temperature and Duration of Action

Pain Clinical Trial

Official title:

Effect of Temperature of Combined Spinal Epidural Dosing on Duration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020304
• Other study ID #: IRB 23933
• Status: Completed
• Phase: Phase 2
• Start date: August 29, 2013
• Est. completion date: May 4, 2014

Study information

• Verified date: September 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 4, 2014
• Est. primary completion date: May 4, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• combined spinal epidural
Combined Spinal Epidural

Locations

Country	Name	City	State
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 3 hours
Secondary	Analgesia Onset-5 Minutes Post Injection		from time of CSE administration
Secondary	Analgesia Onset-10 Minutes Post Injection		up to 3 hours
Secondary	Analgesia Onset-15 Minutes Post Injection		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)	30 minutes