Early Phase 1
N=50
IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Lower Limb Injury
Bottom Line
View on ClinicalTrials.gov: NCT03855059 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Analgesia Duration — 22.1; 25.7 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Placebos (Drug); Dexamethasone Sodium Phosphate (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of Arizona
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analgesia Duration |
22.1; 25.7 | — |
Summary
IV and included steroids have produced the same length of block prolongation in adults as if the steroid was given with the nerve block. Clinically, this has not be noticed in children. The objective of this study is to examine this in young patients. The investigator will blindly give the steroid either in the IV or in the block solution (perineural). This is a prospective double blind study.
Eligibility Criteria
Inclusion Criteria
- Scheduled to have a lower limb Orthopedic surgical procedure.
- Scheduled to have a nerve block placed for post operative analgesia.
- American Society of Anesthesiologist (ASA) Class I - III.
Exclusion Criteria
- Not scheduled to have a nerve block placed for post operative analgesia.
Data sourced from ClinicalTrials.gov (NCT03855059). 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.