Combined Spinal-Epidural Temperature and Duration of Action
Effect of Temperature of Combined Spinal Epidural Dosing on Duration
1 other identifier
interventional
58
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pain
Started Aug 2013
Shorter than P25 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2013
CompletedFirst Submitted
Initial submission to the registry
November 21, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2014
CompletedResults Posted
Study results publicly available
August 24, 2017
CompletedSeptember 10, 2018
September 1, 2018
8 months
November 21, 2013
July 25, 2017
September 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
up to 3 hours
Pruritus
30 minutes
Study Arms (2)
Room temperature
EXPERIMENTALroom temperature combined spinal epidural dose (60-75 degrees F)
refrigerated temperature
ACTIVE COMPARATORrefrigerated temperature combined spinal epidural dose (\~\<43 degrees F)
Interventions
Eligibility Criteria
You may qualify if:
- \>/= 18 years of age not allergic to medications used to treat labor pain \</= 6cm cervical dilation visual pain score \>/=3
You may not qualify if:
- \<18 years of age \> 6 cm cervical dilation non-English speaking subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vernon H Ross MD
- Organization
- Wake Forest School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Vernon Ross, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
December 24, 2013
Study Start
August 29, 2013
Primary Completion
May 4, 2014
Study Completion
May 4, 2014
Last Updated
September 10, 2018
Results First Posted
August 24, 2017
Record last verified: 2018-09