Minimal Opioid Use After Total Hip Replacement (THR)

NCT ID: NCT03090152

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-08
• Study Completion Date: 2019-09-27

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.

Conditions

Osteoarthritis, Hip

Keywords

Total Hip Replacement; Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Periarticular Injection (PAI)

• 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.

Group Type: ACTIVE_COMPARATOR

Periarticular injection (Deep injection)

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.

Placebo

Intervention Type: DRUG

EPCA: Saline.

Epidural Patient-Controlled Analg (EPCA)

• 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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

EPCA: Bupivacaine 0.06%.

PAI + EPCA

• 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.

Group Type: EXPERIMENTAL

Periarticular injection (Deep injection)

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.

Bupivacaine

Intervention Type: DRUG

EPCA: Bupivacaine 0.06%.

Interventions

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.

Intervention Type: PROCEDURE

Periarticular injection (Superficial injection)

Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.

Intervention Type: PROCEDURE

Bupivacaine

EPCA: Bupivacaine 0.06%.

Intervention Type: DRUG

Placebo

EPCA: Saline.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kethy Jules-Elysee, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-0721

Identifier Type: -

Identifier Source: org_study_id