Readiness to Discharge
Conditions
Brief summary
There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.
Interventions
PROCEDUREPeri-Articular Injection
Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
PROCEDUREEpidural Pathway (PCEA+FNB)
Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon * Age 18 to 85 years old * Planned use of regional anesthesia * Ability to follow study protocol * Up to 15 degrees varus, up to 15 degrees flexion and up to 15 degrees valgus
Exclusion criteria
* Patients younger than 18 years old and older than 85 * 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 open knee surgery. * Patients with flexion contracture of knee \> 15 degrees * Patients with varus deformity \> 15 degrees * Patients with valgus deformity \> 15 degrees * Patients with a contraindication to use of epinephrine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome is Time Until a Patient is Ready for Discharge. | Participants will be followed for the duration of their hospital stay, an expected average of 3 days | The primary outcome is time until a patient is ready for discharge. Discharge criteria are: * PCA (if present) has been discontinued * Not experiencing moderate or severe nausea (within last 4 hours). * Solid food diet * Able to urinate (Foley catheter removed) * Pain: NRS \<4. * Surgical wound dry * No acute medical problems * Physical Therapy Criteria * Independently transfer from supine to sit, from sitting to standing * Ambulate 40 ft. without assistance * Extension range of motion (\< 10 degrees) |
Countries
United States
Participant flow
Pre-assignment details
One patient in the local infiltration group was deemed ineligible due to a rheumatoid arthritis. Only 90 patients were randomized to the study.
Participants by arm
| Arm | Count |
|---|---|
| Epidural Pathway meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV | 45 |
| Local Infiltration meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN) | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Epidural Pathway | Local Infiltration | Total |
|---|---|---|---|
| Age, Continuous | 67 years | 65 years | 66 years |
| BMI Morbidly Obese | 2 participants | 3 participants | 5 participants |
| BMI Normal | 3 participants | 2 participants | 5 participants |
| BMI Obese | 21 participants | 20 participants | 41 participants |
| BMI Overweight | 19 participants | 20 participants | 39 participants |
| Region of Enrollment United States | 45 participants | 45 participants | 90 participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 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
The Primary Outcome is Time Until a Patient is Ready for Discharge.
The primary outcome is time until a patient is ready for discharge. Discharge criteria are: * PCA (if present) has been discontinued * Not experiencing moderate or severe nausea (within last 4 hours). * Solid food diet * Able to urinate (Foley catheter removed) * Pain: NRS \<4. * Surgical wound dry * No acute medical problems * Physical Therapy Criteria * Independently transfer from supine to sit, from sitting to standing * Ambulate 40 ft. without assistance * Extension range of motion (\< 10 degrees)
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Epidural Pathway | The Primary Outcome is Time Until a Patient is Ready for Discharge. | 3.2 days |
| Local Infiltration | The Primary Outcome is Time Until a Patient is Ready for Discharge. | 3.2 days |