Phase 2
Completed N=58
Combined Spinal-Epidural Temperature and Duration of Action
Source: ClinicalTrials.gov NCT02020304 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Time — 74; 81 minutes
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.
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 | — |
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. Informational only — not medical advice.