Minimal Opioid Use After Total Hip Replacement (THR)
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      Total hip arthroplasty can be associated with significant postoperative pain. Side effects of
      pain management may impair participation in physical therapy and slow readiness for discharge
      from the hospital. In a previous study done by the investigators' group, epidural patient
      controlled analgesia (EPCA) with a hydromorphone containing solution appeared to have a more
      favorable pain profile with ambulation, but greater side effects compared to injection of a
      peri-articular cocktail. The use of opioid was greater in the peri-articular injection group
      (PAI). There was no difference in length of stay. In view of the controversy over opioid use,
      the investigators would like to develop an optimal opioid sparing pain management approach by
      comparing 3 different protocols 1) Plain local anesthetic EPCA; 2) PAI; 3) EPCA + PAI; all in
      conjunction with a multimodal opioid sparing pain regimen. The goal would be to maximize pain
      control while minimizing opioid use and side-effects.
    

Detailed description: 
      Long acting narcotics or scheduled doses of narcotics are often used as part of a multimodal
      pain regimen. In this study, this is eliminated. Instead, it uses a cocktail of different
      drugs including intraoperative Ketamine use (NMDA receptor antagonist), intra-op Benadryl (to
      decrease excitation of nociceptors) and IV Tylenol. The narcotic free regimen starts
      preoperatively with the use of Aspirin,Clonidine patch, Cymbalta (Duloxetine), and is
      maintained both intraoperatively and post operatively. Baby ASA (81mg) is being used as an
      anti-inflammatory agent. A number of studies including the one by Morris et al. (2009), have
      shown via in vitro experiments that low dose aspirin decreases polymorphonuclear leukocyte
      and macrophage accumulation. It inhibits thromboxane making it an antithrombotic agent as
      well. The concern with aspirin has been major bleeding. Several studies in the orthopedic
      patient population using ≤81 mg of aspirin have shown that it does not increase bleeding
      (Cuellar, Mantz). At HSS, patients are routinely continued on baby aspirin when needed for
      its cardio protective effect. Devereaux in the POISE trial did show an increased risk of
      bleeding when ASA was given preoperatively at a dose of 200 mg. In our study, all patients
      will be given intravenous tranexamic acid which should mitigate against the risk of bleeding.
      Duloxetine is also being added. In a recent study done at HSS. Duloxetine was found to
      decrease the amount of opioid use and nausea. If found to be more effective with the use of
      EPCA vs. PAI or combination of the two, a new way of managing postop pain while minimizing
      Nnartcuoreti co fu Ssetu adsy per CDC recommendation will be helpful in managing patients
      post-operatively.
    

Intervention name(s): Periarticular injection (Deep injection); Periarticular injection (Superficial injection); Bupivacaine; Placebo
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.; Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.; EPCA: Bupivacaine 0.06%.; EPCA: Saline.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Hip Replacement; Total Hip Arthroplasty