Minimal Opioid Use After Total Hip Replacement (THR)

Phase 4

Completed

• Conditions: Osteoarthritis, Hip
• Interventions: Procedure: Periarticular injection (Deep injection); Drug: Bupivacaine; Procedure: Periarticular injection (Superficial injection); Drug: Placebo

• Registration Number: NCT03090152
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-08
• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Primary Completion: 2019-06-28
• Study Completion: 2019-09-27
• Results First Submitted: 2022-03-31
• Results First Submitted QC: 2022-07-26
• Results First Posted: 2022-07-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periarticular Injection (PAI)	Periarticular injection (Deep injection)	* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. * Peri-articular injection in the operating room * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular Injection (PAI)	Periarticular injection (Superficial injection)	* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. * Peri-articular injection in the operating room * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular Injection (PAI)	Placebo	* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. * Peri-articular injection in the operating room * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
PAI + EPCA	Periarticular injection (Deep injection)	* Aspirin and nerve pain medications including duloxetine and clonidine * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * Anesthetic, Antiemetic and peri-articular injection in the operating room * A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Epidural Patient-Controlled Analg (EPCA)	Bupivacaine	* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery. * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
PAI + EPCA	Periarticular injection (Superficial injection)	* Aspirin and nerve pain medications including duloxetine and clonidine * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * Anesthetic, Antiemetic and peri-articular injection in the operating room * A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
PAI + EPCA	Bupivacaine	* Aspirin and nerve pain medications including duloxetine and clonidine * Combined Spinal Epidural with 1.5% Mepivacaine 4cc * Anesthetic, Antiemetic and peri-articular injection in the operating room * A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available. * Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.

Primary Outcome Measures

Name	Time	Method
Opioid Use	within 24 hours after surgery	Oral morphine equivalents, cumulative

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States