Minimal Opioid Use After Total Hip Replacement (THR)
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2017
CompletedFirst Submitted
Initial submission to the registry
March 13, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2019
CompletedResults Posted
Study results publicly available
July 27, 2022
CompletedDecember 27, 2024
April 1, 2024
2.3 years
March 13, 2017
March 31, 2022
December 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Opioid Use
Oral morphine equivalents, cumulative
within 24 hours after surgery
Secondary Outcomes (11)
Pain at Rest
Postoperative Day 1,2,3,7,90
Pain With Activity
Postoperative Day 1,2,3,7,90
Opioid Side Effects
Postoperative Day 1,2
Patient Satisfaction
Postoperative Day 1,2,3,7
Post-operative Pain
Postoperative Day 1
- +6 more secondary outcomes
Study Arms (3)
Periarticular Injection (PAI)
ACTIVE COMPARATOR* 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.
Epidural Patient-Controlled Analg (EPCA)
ACTIVE COMPARATOR* 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
EXPERIMENTAL* 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.
Interventions
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.
Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kethy Jules-Elysee
- Organization
- Hospital for Special Surgery
Study Officials
- PRINCIPAL INVESTIGATOR
Kethy Jules-Elysee, MD
Hospital for Special Surgery, New York
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2017
First Posted
March 24, 2017
Study Start
March 8, 2017
Primary Completion
June 28, 2019
Study Completion
September 27, 2019
Last Updated
December 27, 2024
Results First Posted
July 27, 2022
Record last verified: 2024-04