Phase 4
N=180
Minimal Opioid Use After Total Hip Replacement (THR)
Osteoarthritis, Hip
Bottom Line
View on ClinicalTrials.gov: NCT03090152 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Opioid Use — 30; 22.5; 15 Oral Morphine Equivalent (mg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Periarticular injection (Deep injection) (Procedure); Periarticular injection (Superficial injection) (Procedure); Bupivacaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Use |
30; 22.5; 15 | — |
| SECONDARY Pain at Rest |
2; 1.9; 1.7; 2.2; 1.8; 1.9 | — |
| SECONDARY Pain With Activity |
3.6; 3.4; 3.7; 4.2; 3.6; 4 | — |
| SECONDARY Opioid Side Effects |
0.8; 0.6; 0.9; 1.1; 0.6; 1.3 | — |
| SECONDARY Patient Satisfaction |
9.6; 9.6; 9.5; 9.3; 9.1; 9.1 | — |
| SECONDARY Post-operative Pain |
5.5; 5; 4; 0; 0; 0 | — |
| SECONDARY Neuropathic Pain Assessed With S-LANSS |
8; 8; 7.5; 8; 8; 8 | — |
| SECONDARY Quality of Recovery |
102.2; 102.3; 101.6; 102.9; 103.1; 102.1 | — |
| SECONDARY Readiness for Discharge Time |
46.5; 48.7; 48.8 | — |
| SECONDARY Blinding Assessment |
5; 13; 7; 10; 10; 6 | — |
| SECONDARY Opioid Consumption During the First 3 Days Post-op |
52.5; 45; 40 | — |
| SECONDARY No Opioids Consumed |
5; 12; 14 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT03090152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.