Phase 2
N=58
Combined Spinal-Epidural Temperature and Duration of Action
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02020304 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Time — 74; 81 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- combined spinal epidural (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time |
74; 81 | — |
| SECONDARY Analgesia Onset-5 Minutes Post Injection |
24; 14 | — |
| SECONDARY Analgesia Onset-10 Minutes Post Injection |
25; 19 | — |
| SECONDARY Analgesia Onset-15 Minutes Post Injection |
25; 24 | — |
| SECONDARY Pruritus |
2; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- >/= 18 years of age not allergic to medications used to treat labor pain /=3
Exclusion Criteria
- 6 cm cervical dilation non-English speaking subjects
Data sourced from ClinicalTrials.gov (NCT02020304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.