Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy
Condition: Knee Injury
MeSH terms: Knee Injuries
Study type: Interventional
Phase: Phase 3

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%.
    

Detailed description: 
      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:

        1. Standard American Society of Anesthesiologists (ASA) monitors will be placed on the
           patient (ECG, pulse oximetry, non-invasive BP, thermistor).

        2. A peripheral intravenous catheter will be placed while patient is inhaling 50% nitrous
           oxide.

        3. Intravenous induction will be accomplished with midazolam 2 mg, propofol 2-3 mg/kg.

        4. Once induction is complete, a laryngeal mask airway will be placed.

        5. Maintenance of anesthesia will be provided with inhaled sevoflurane titration.

        6. The femoral nerve block will be performed by one of the anesthesiologist
           co-investigators.

        7. After completion of a pre-block time-out, the patient's groin on side of surgery will be
           prepped with chlorhexidine.

        8. Using aseptic technique, a needle will be advanced under ultrasound guidance to the
           femoral nerve.

        9. In addition to ultrasound, a nerve stimulator may be used at the anesthesiologist's
           discretion to help identify the femoral nerve.

       10. After identification of the femoral nerve, the perineural study drug will be injected
           around the femoral nerve.

       11. Using aseptic technique the intramuscular study drug will be injected into the gluteus
           muscle.

       12. For intraoperative increases in heart rate or systolic blood pressure >20 % above levels
           immediately prior to incision, fentanyl will be given in 1 µg/kg increments every 5
           minutes until below this threshold. (No acetaminophen, ketorolac, or IV dexamethasone
           will be given)

       13. Once the patient arrives to PACU, dilaudid 5 µg/kg (max. dose 0.3 mg) every ten minutes
           may be given until patient VAS score is less than or equal to 4.

       14. In the surgery unit, patients may receive one dose of hydrocodone-acetaminophen (7.5
           mg/325 mg/15 ml) liquid suspension 0.1 mg/kg hydrocodone PO (max. dose 10mg hydrocodone)
           and then may receive dilaudid 5 µg/kg IV if pain persists above a VAS of 4 (max. dose
           0.3 mg).

       15. Patients will be discharged from the surgery unit with a prescription for
           hydrocodone-acetaminophen (7.5 mg/325 mg/15 ml) liquid suspension. The prescription will
           be for 0.1 mg/kg hydrocodone PO (max. dose 10 mg hydrocodone) every 4 hours as needed
           for all patients.

       16. Patients will be sent home with a pain diary to record consumption of pain medication,
           when 1st dose of pain medications was taken, when sensory and motor blocks resolved and
           degree of motor block 24 and 48 hours according to the Bromage scale (Table 1). All
           adverse effects including nausea, vomiting, pruritus, excessive sedation will be asked
           to be recorded in the diary.

       17. A clinical research nurse will collect information on opioid consumption on day of
           surgery (DOS) and intensity of motor block in PACU according to the Bromage scale.

       18. On post-operative day 1 and 2 a clinical research nurse will call to collect information
           from the diary for analysis. If sensory or motor blockade persists on day 2, then the
           patient will be called on day 3. If neurologic symptoms persist after 72 hours, the
           patient will be asked to come to pre-operative clinic for a neurologic examination by an
           anesthesiologist. If neurological deficits are present on exam, the patient will be
           referred to a neurologist. Neurology will then determine if further testing is required.
           In addition, all patients will be contacted by telephone at 2 weeks after study
           initiation. If any new neurologic deficits are reported at this time, patients will be
           brought into the preoperative clinic and undergo the same evaluations.
    

Intervention name(s): Dexamethasone; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Dexamethasone; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexamethasone; Ropivacaine; Knee arthroscopy; Femoral nerve blocks; Peripheral nerve blocks; Adjuvant; Pediatrics