Minimal Opioid Use After Total Hip Replacement (THR)

Osteoarthritis, Hip Clinical Trial

Official title:

Minimal Opioid Use After Total Hip Replacement (THR): a Blinded Randomized Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090152
• Other study ID #: 2016-0721
• Status: Completed
• Phase: Phase 4
• Start date: March 8, 2017
• Est. completion date: September 27, 2019

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 27, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Procedure:
• Periarticular injection (Deep injection)
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.
• Periarticular injection (Superficial injection)
Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.

Drug:
• Bupivacaine
EPCA: Bupivacaine 0.06%.
• Placebo
EPCA: Saline.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use	Oral morphine equivalents, cumulative	within 24 hours after surgery
Secondary	Pain at Rest	NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.	Postoperative Day 1,2,3,7,90
Secondary	Pain With Activity	NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.	Postoperative Day 1,2,3,7,90
Secondary	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.	Postoperative Day 1,2
Secondary	Patient Satisfaction	via Likert scale. A higher score is a better outcome. the scale is from 0-10.	Postoperative Day 1,2,3,7
Secondary	Post-operative Pain	via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes.	Postoperative Day 1
Secondary	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.	Postoperative Day 7, Postoperative Day 90
Secondary	Quality of Recovery	Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome	Postoperative Day 1,2,3
Secondary	Readiness for Discharge Time	When patient meets all readiness for discharge criteria	From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.
Secondary	Blinding Assessment	What group do you think you were in	Assessed on day of discharge and on seventh post operative day
Secondary	Opioid Consumption During the First 3 Days Post-op	Opioids consumed in the first 3 after surgery (cumulative consumption).	Postoperative day 0,1,2,3
Secondary	No Opioids Consumed	Number of patients who did not consume any opioids	0 to 24 hours post-operatively