Clinical trial NCT03090152: Minimal Opioid Use After Total Hip Replacement (THR)
Official title: Minimal Opioid Use After Total Hip Replacement (THR): a Blinded Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Keywords: Total Hip Replacement
Total Hip Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Any patient with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
* Planned use of regional anesthesia
* Planned posterolateral surgical approach
* Age Range 45-80
* Ability to follow study protocol

Exclusion Criteria:

* Any patient with age \<45 or \>80
* Any patient with planned anterior surgical approach
* Any patient with prior major ipsilateral hip surgery
* Any patient intending to receive general anesthesia
* Any patient with an ASA of IV
* Any patient with insulin-dependent diabetes
* Any patient with hepatic (liver) failure (history of cirrhosis or elevated LFT's)
* Any patient with chronic renal (kidney) failure (formal diagnosis of renal disease of elevated creatinine)
* Any patient with history of gastric (stomach) ulcer
* Chronic opioid use (taking opioids for \>3 mo duration on a daily basis)
* Chronic analgesic use (i.e. lyrica, gabapentin) for \>3 mo duration
* Stress dose steroids
* Use of antidepressants
* Contraindications to aspirin
* Allergy to any of the medications (or adhesives) involved in the study protocol
* Dementia
* Non-English speakers.

Primary outcomes:
measure: Opioid Use
timeFrame: within 24 hours after surgery
Secondary outcomes:
measure: Pain at Rest
timeFrame: Postoperative Day 1,2,3,7,90
measure: Pain With Activity
timeFrame: Postoperative Day 1,2,3,7,90
measure: Opioid Side Effects
timeFrame: Postoperative Day 1,2
measure: Patient Satisfaction
timeFrame: Postoperative Day 1,2,3,7
measure: Post-operative Pain
timeFrame: Postoperative Day 1
measure: Neuropathic Pain Assessed With S-LANSS
timeFrame: Postoperative Day 7, Postoperative Day 90
measure: Quality of Recovery
timeFrame: Postoperative Day 1,2,3
measure: Readiness for Discharge Time
timeFrame: From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.
measure: Blinding Assessment
timeFrame: Assessed on day of discharge and on seventh post operative day
measure: Opioid Consumption During the First 3 Days Post-op
timeFrame: Postoperative day 0,1,2,3
measure: No Opioids Consumed
timeFrame: 0 to 24 hours post-operatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Kethy Jules-Elysee, MD
role: PRINCIPAL_INVESTIGATOR
References: