Lower Limb Injury
Conditions
Brief 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.
Detailed description
The subject has a 50/50 chance of receiving either cohort. After the subject is randomized to receive either steroid given IV or with the nerve block, the subject is anesthetized and the subject will receive either an IV injection of 5 cc steroids or placebo, and 20 cc local anesthetic plus placebo or steroid in the nerve block, the block will be placed under ultrasound to insure proper placement of block, the dose of steroid is based on weight, 0.1 - 0.15 mg/kg. The investigator will record the time of block and IV injection. The subjects will be called by the study PI after 24 hours to determine the time of duration and again at 48 hours if needed. This is a randomized, double blind study, neither the subject or the anesthesiologist giving the injection will know what is being given. The medications will be prepared and dispensed by the Research pharmacist, a randomization chart will be obtained by the research pharmacist.
Interventions
DRUGPlacebos
This will be a saline solution of given IV or perineural.
DRUGDexamethasone Sodium Phosphate
This will be the active drug solution given IV or perineural.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The research pharmacist will randomize and prepare the necessary syringes for injection to look similar and have the same amount of solution as so the PI and anyone else does not know what is being given.
Intervention model description
Double blind study
Eligibility
Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia Duration | 24 - 48 hours | The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervenous Steroid Steroid given intervenously at the time of Peripheral nerve block | 25 |
| Perineural Steroid Steroid given in syringe with the local anesthetic | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Intervenous Steroid | Perineural Steroid | Total |
|---|---|---|---|
| Age, Customized Population age | 13.24 years | 11.28 years | 12.26 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Analgesia Duration
The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia.
Time frame: 24 - 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervenous Steroid | Analgesia Duration | 22.1 Hours | Standard Deviation 8.9 |
| Perineural Steroid | Analgesia Duration | 25.7 Hours | Standard Deviation 9.8 |