Phase 3
N=77
Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy
Knee Injury
Bottom Line
View on ClinicalTrials.gov: NCT01971645 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Intra-operative and Post-operative Opioid Consumption — 2; 2; 3 doses
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Ropivacaine (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Nationwide Children's Hospital
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-operative and Post-operative Opioid Consumption |
2; 2; 3 | — |
| SECONDARY Post-operative Pain Scores |
2; 2; 1 | — |
Summary
If preservative-free dexamethasone 0.1 mg/kg (max dose 4 mg) is added to ropivacaine 0.5% 2 mg/kg (max dose 100 mg), then post-PACU opioid consumption will be reduced by 33%.
Eligibility Criteria
Inclusion Criteria
- Children older than 10, and younger than 19 years of age undergoing unilateral arthroscopic surgery of the knee
- American Society of Anesthesiologists (ASA) Status I or II
- Patient's parent/guardian willing and able to give consent
- Patient willing to give assent
Exclusion Criteria
- Arthroscopic anterior cruciate ligament repair
- Systemic steroid use within the last 3 months
- Diabetes mellitus
- Females testing positive for pregnancy
- BMI > 98th percentile
- Positive pregnancy test
- Coagulopathy
- Renal or hepatic disease
- Pre-existing motor or sensory deficits in the lower extremities
- Predisposition for falls based on pre-existing sensory or motor deficits of the legs or inability to perform crutch training.
- Non-English speaking
- Systemic fungal infection
- Immunosuppressed patients
Data sourced from ClinicalTrials.gov (NCT01971645). 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.