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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
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.
Hospital for Special Surgery
New York, New York, United States
Opioid Use
Oral morphine equivalents, cumulative
Time frame: within 24 hours after surgery
Pain at Rest
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Time frame: Postoperative Day 1,2,3,7,90
Pain With Activity
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Time frame: Postoperative Day 1,2,3,7,90
Opioid Side Effects
via ORSDS (Opioid-Related Symptom Distress Scale). Each symptom was rated on a 4 point scale from 0-4. A lower score is a better outcome.
Time frame: Postoperative Day 1,2
Patient Satisfaction
via Likert scale. A higher score is a better outcome. the scale is from 0-10.
Time frame: Postoperative Day 1,2,3,7
Post-operative Pain
via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes.
Time frame: Postoperative Day 1
Neuropathic Pain Assessed With S-LANSS
via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs). Scores range from 0-24. A lower score is a better outcome.
Time frame: Postoperative Day 7, Postoperative Day 90
Quality of Recovery
Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome
Time frame: Postoperative Day 1,2,3
Readiness for Discharge Time
When patient meets all readiness for discharge criteria
Time frame: From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.
Blinding Assessment
What group do you think you were in
Time frame: Assessed on day of discharge and on seventh post operative day
Opioid Consumption During the First 3 Days Post-op
Opioids consumed in the first 3 after surgery (cumulative consumption).
Time frame: Postoperative day 0,1,2,3
No Opioids Consumed
Number of patients who did not consume any opioids
Time frame: 0 to 24 hours post-operatively
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