Osteoarthritis
Conditions
Keywords
Total Hip Arthroplasty, Total Hip Replacement
Brief summary
The best way to provide analgesia after total hip arthroplasty is hotly debated. There are two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their proponents, but there are limited data for making an informed choice of protocols. For total hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with physical therapy. However, epidural analgesia can be associated with nausea, pruritis, dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided to use a different analgesic protocol, based on a peri-articular injection. This protocol avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as part of a multimodal pain therapy. The investigators propose to compare peri-articular injection to epidural patient controlled analgesia (Epidural PCA). The investigators will enroll 90 total patients (45 per study arm). The enrollment period will be approximately one year and the duration of the follow-up with study patients will be three months following their procedure.
Interventions
PROCEDUREPeri-Articular Injection
Use of a different analgesic protocol, based on a peri-articular injection
PROCEDUREEpidural Patient Controlled Analgesia (Epidural PCA)
Epidural analgesia pathway.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon * Age 50 to 80 years old * Planned use of regional anesthesia * Ability to follow study protocol
Exclusion criteria
* Patients younger than 50 years old and older than 80 * Patients intending to receive general anesthesia * Allergy or intolerance to one of the study medications * Patients with an ASA of IV * Patients with insulin-dependent diabetes * Patients with hepatic (liver) failure * Patients with chronic renal (kidney) failure * Chronic opioid use (taking opioids for longer than 3 months) * Patients with any prior major ipsilateral hip surgery * Allergy to any of the medications (or adhesives) involved in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Until Patient is Ready for Discharge | Length of Hospital Stay, an expected average of 3 days | readiness for discharge to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peri-Articular Injection Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection | 41 |
| Epidural Patient Controlled Analgesia (Epidural PCA) Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway. | 43 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 4 | 2 |
Baseline characteristics
| Characteristic | Peri-Articular Injection | Epidural Patient Controlled Analgesia (Epidural PCA) | Total |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 8.5 | 64.8 years STANDARD_DEVIATION 7.1 | 64.3 years STANDARD_DEVIATION 7.8 |
| Body mass index | 28.0 kg/(m^2) STANDARD_DEVIATION 5.4 | 27.9 kg/(m^2) STANDARD_DEVIATION 6.2 | 28.0 kg/(m^2) STANDARD_DEVIATION 5.8 |
| Region of Enrollment United States | 41 participants | 43 participants | 84 participants |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Male | 20 Participants | 24 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Time Until Patient is Ready for Discharge
readiness for discharge to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty.
Time frame: Length of Hospital Stay, an expected average of 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injection | Time Until Patient is Ready for Discharge | 2.4 days | Standard Deviation 0.7 |
| Epidural Patient Controlled Analgesia (Epidural PCA) | Time Until Patient is Ready for Discharge | 2.3 days | Standard Deviation 0.8 |