Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee
Condition: Unilateral Knee Arthroplasty
MeSH terms: Muscle Hypotonia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, three-arm, randomized, open-label trial to determine if a new pain
      control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine
      for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces
      average pain scores.
    

Detailed description: 
      This research will be a prospective, three-arm, randomized, open-label trial to assess opioid
      use and patient reported outcomes after 48 hours of regular IV acetaminophen and muscle
      relaxant (IVAM) orphenadrine administration following total knee replacement surgery. 180
      patients (60 in each arm) will be randomized to receive the standard group treatment, the
      IVAM group treatment, or to the control grouptreatment.

      Standard Group Treatment: includes peripheral nerve single injection or catheter infusions
      (48 hours) as requested by the surgeon; preoperative (single dose) intravenous acetaminophen
      (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as
      determined by the anesthesia attending physician; postoperative oral oxycodone (5 mg) with
      acetaminophen (325 mg) (PRN dosing), oral orphenadrine (100 mg) every 12 hours for 3 doses,
      and intravenous hydromorphone (PRN dosing) for breakthrough pain.

      Control Group Treatment: includes peripheral nerve single injection or catheter infusions (48
      hours); preoperative (single dose) intravenous acetaminophen (1000 mg) intraoperative spinal
      anesthesia or general anesthesia as determined by the anesthesia attending physician; and
      postoperative oral oxycodone and acetaminophen (PRN dosing), and intravenous hydromorphone
      (PRN dosing) for breakthrough pain.

      IVAM Group Treatment: includes peripheral nerve single injection or catheter infusions (48
      hours); preoperative intravenous acetaminophen (1000 mg) and orphenadrine (60 mg);
      intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia
      attending physician; postoperative intravenous acetaminophen (1000 mg) every 6 hours routine
      for total of 8 doses and intravenous orphenadrine (60 mg) every 12 hours for total of 4
      doses; oral oxycodone (5 mg) (PRN dosing), and intravenous hydromorphone (PRN dosing) for
      breakthrough pain.
    

Intervention name(s): Preop acetaminophen IV; Preop orphenadrine IV; Postop oral oxycodone & acetaminophen; Postop hydromorphone IV; Postop oral orphenadrine; Postop oral oxycodone; Postop acetaminophen IV; Postop orphenadrine IV
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Ofirmev; Norflex; Percocet; Dilaudid; Norflex; Roxicodone; Ofirmev; Norflex
Intervention MeSH terms: Acetaminophen; Oxycodone; Hydromorphone; Orphenadrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment