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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-Articular Injection | Experimental |
| |
| Epidural Patient Controlled Analgesia (Epidural PCA) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peri-Articular Injection | Procedure | Use of a different analgesic protocol, based on a peri-articular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Length of Hospital Stay, an expected average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kethy M Jules-Elysee, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peri-Articular Injection | Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection |
| FG001 | Epidural Patient Controlled Analgesia (Epidural PCA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Epidural Patient Controlled Analgesia (Epidural PCA) | Procedure | Epidural analgesia pathway. |
|
Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peri-Articular Injection | Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection |
| BG001 | Epidural Patient Controlled Analgesia (Epidural PCA) | Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | Mean | Standard Deviation | kg/(m^2) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | days | Length of Hospital Stay, an expected average of 3 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peri-Articular Injection | Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection | 0 | 45 | 0 | 45 | ||
| EG001 | Epidural Patient Controlled Analgesia (Epidural PCA) | Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway. | 0 | 45 | 0 | 45 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kethy Jules-Elysee, MD | Hospital for Special Surgery | 2126061206 | juleselyseek@hss.edu |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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