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Minimal Opioid Use After Total Hip Replacement (THR)

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ClinicalTrials.gov Identifier: NCT03090152
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Procedure: Periarticular injection (Deep injection) Procedure: Periarticular injection (Superficial injection) Drug: Bupivacaine Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimal Opioid Use After Total Hip Replacement (THR): a Blinded Randomized Placebo-controlled Study
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: 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.
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.

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

Drug: Placebo
EPCA: Saline.

Active Comparator: 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.
Drug: Bupivacaine
EPCA: Bupivacaine 0.06%.

Experimental: 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.
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.

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

Drug: Bupivacaine
EPCA: Bupivacaine 0.06%.




Primary Outcome Measures :
  1. Opioid use [ Time Frame: within 24 hours after surgery ]
    Oral morphine equivalents, cumulative


Secondary Outcome Measures :
  1. Pain at rest [ Time Frame: Postoperative Day 1,2,3,7,90 ]
    via NRS (Numeric Pain Rating Scale)

  2. Pain with activity [ Time Frame: Postoperative Day 1,2,3,7,90 ]
    via NRS (Numeric Pain Rating Scale)

  3. Opioid side effects [ Time Frame: Postoperative Day 1,2 ]
    via ORSDS (Opioid-Related Symptom Distress Scale)

  4. Patient satisfaction [ Time Frame: Postoperative Day 1,2,3,7,90 ]
    via Likert scale

  5. Post-operative pain [ Time Frame: Postoperative Day 1 ]
    via PAINOUT (Improvement in postoperative PAIN OUTcome)

  6. Neuropathic pain [ Time Frame: Postoperative Day 7, Postoperative Day 90 ]
    via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs)

  7. Neuropathic pain [ Time Frame: Postoperative Day 7, Postoperative Day 90 ]
    via SF-8 (Short Form Health Survey)

  8. Quality of recovery [ Time Frame: Postoperative Day 1,2,3 ]
    Via QoR-40 (Quality of Recovery)

  9. Readiness for discharge time [ Time Frame: 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



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 50-75
  • Ability to follow study protocol

Exclusion Criteria:

  • Any patient with age <50 or >75
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090152


Contacts
Contact: Carrie A Freeman, BS 646-797-8948 FreemanC@HSS.edu
Contact: Danya DeMeo, BS 212-774-2678 demeod@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Principal Investigator: Kethy Jules-Elysee, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Kethy Jules-Elysee, MD Hospital for Special Surgery, New York

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03090152     History of Changes
Other Study ID Numbers: 2016-0721
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital for Special Surgery, New York:
Total Hip Replacement
Total Hip Arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Analgesics, Opioid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Analgesics