Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
NCT Number: NCT01971645
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%.
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Notify Me10 year–19 year
All sexes
Interventional
Phase 3
Columbus, Ohio, 43205, United States
Following informed consent, patients will be randomized to one (1) of three (3) arms. Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml). Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml). Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg). The randomization will be blinded to the patient, surgery team, anesthesia team, recovery nurses, and clinical research nurses.
The remainder of the anesthetic care will remain the same per our usual routine for these cases. On arrival to the operating room:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
Time frame: Intra-operative and up to 48 hours post-discharge, an average of 48 hours
Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Time frame: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.
Nationwide Children's Hospital
Other
Dexamethasone as an Adjuvant to Ropivacaine for Femoral Nerve Blocks in Children Undergoing Knee Arthroscopy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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