Osteoarthritis, Hip
Conditions
Keywords
Total Hip Replacement, Total Hip Arthroplasty
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.
Detailed description
Long acting narcotics or scheduled doses of narcotics are often used as part of a multimodal pain regimen. In this study, this is eliminated. Instead, it uses a cocktail of different drugs including intraoperative Ketamine use (NMDA receptor antagonist), intra-op Benadryl (to decrease excitation of nociceptors) and IV Tylenol. The narcotic free regimen starts preoperatively with the use of Aspirin,Clonidine patch, Cymbalta (Duloxetine), and is maintained both intraoperatively and post operatively. Baby ASA (81mg) is being used as an anti-inflammatory agent. A number of studies including the one by Morris et al. (2009), have shown via in vitro experiments that low dose aspirin decreases polymorphonuclear leukocyte and macrophage accumulation. It inhibits thromboxane making it an antithrombotic agent as well. The concern with aspirin has been major bleeding. Several studies in the orthopedic patient population using ≤81 mg of aspirin have shown that it does not increase bleeding (Cuellar, Mantz). At HSS, patients are routinely continued on baby aspirin when needed for its cardio protective effect. Devereaux in the POISE trial did show an increased risk of bleeding when ASA was given preoperatively at a dose of 200 mg. In our study, all patients will be given intravenous tranexamic acid which should mitigate against the risk of bleeding. Duloxetine is also being added. In a recent study done at HSS. Duloxetine was found to decrease the amount of opioid use and nausea. If found to be more effective with the use of EPCA vs. PAI or combination of the two, a new way of managing postop pain while minimizing Nnartcuoreti co fu Ssetu adsy per CDC recommendation will be helpful in managing patients post-operatively.
Interventions
PROCEDUREPeriarticular injection (Deep injection)
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.
PROCEDUREPeriarticular injection (Superficial injection)
Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
DRUGBupivacaine
EPCA: Bupivacaine 0.06%.
DRUGPlacebo
EPCA: Saline.
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 75 Years
Healthy volunteers
No
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 \<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 * Dementia * Non-English speakers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | within 24 hours after surgery | Oral morphine equivalents, cumulative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Rest | Postoperative Day 1,2,3,7,90 | NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome. |
| Opioid Side Effects | Postoperative Day 1,2 | via ORSDS (Opioid-Related Symptom Distress Scale). Each symptom was rated on a 4 point scale from 0-4. A lower score is a better outcome. |
| Patient Satisfaction | Postoperative Day 1,2,3,7 | via Likert scale. A higher score is a better outcome. the scale is from 0-10. |
| Post-operative Pain | Postoperative Day 1 | via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes. |
| Neuropathic Pain Assessed With S-LANSS | Postoperative Day 7, Postoperative Day 90 | via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs). Scores range from 0-24. A lower score is a better outcome. |
| Pain With Activity | Postoperative Day 1,2,3,7,90 | NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome. |
| Readiness for Discharge Time | From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week. | When patient meets all readiness for discharge criteria |
| Blinding Assessment | Assessed on day of discharge and on seventh post operative day | What group do you think you were in |
| Opioid Consumption During the First 3 Days Post-op | Postoperative day 0,1,2,3 | Opioids consumed in the first 3 after surgery (cumulative consumption). |
| No Opioids Consumed | 0 to 24 hours post-operatively | Number of patients who did not consume any opioids |
| Quality of Recovery | Postoperative Day 1,2,3 | Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Periarticular Injection (PAI) * 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.
Periarticular injection (Deep injection): 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.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline. | 59 |
| Epidural Patient-Controlled Analg (EPCA) * 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.
Bupivacaine: EPCA: Bupivacaine 0.06%. | 56 |
| PAI + EPCA * 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.
Periarticular injection (Deep injection): 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.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%. | 59 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Epidural catheter could not be placed | 0 | 2 | 0 |
| Overall Study | Surgery Canceled | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Periarticular Injection (PAI) | Total | PAI + EPCA | Epidural Patient-Controlled Analg (EPCA) |
|---|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 8 | 64 years STANDARD_DEVIATION 7 | 64 years STANDARD_DEVIATION 7 | 64 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 165 Participants | 57 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 54 Participants | 163 Participants | 56 Participants | 53 Participants |
| Region of Enrollment United States | 59 participants | 174 participants | 59 participants | 56 participants |
| Sex: Female, Male Female | 29 Participants | 84 Participants | 32 Participants | 23 Participants |
| Sex: Female, Male Male | 30 Participants | 90 Participants | 27 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
Outcome results
Primary
Opioid Use
Oral morphine equivalents, cumulative
Time frame: within 24 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Periarticular Injection (PAI) | Opioid Use | 30 Oral Morphine Equivalent (mg) |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Use | 22.5 Oral Morphine Equivalent (mg) |
| PAI + EPCA | Opioid Use | 15 Oral Morphine Equivalent (mg) |
Secondary
Blinding Assessment
What group do you think you were in
Time frame: Assessed on day of discharge and on seventh post operative day
Population: Lost to follow up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Periarticular Injection (PAI) | Blinding Assessment | Discharge | PAI | 5 Participants |
| Periarticular Injection (PAI) | Blinding Assessment | Discharge | EPCA | 10 Participants |
| Periarticular Injection (PAI) | Blinding Assessment | Discharge | PAI+EPCA | 18 Participants |
| Periarticular Injection (PAI) | Blinding Assessment | Discharge | Do Not Know | 17 Participants |
| Periarticular Injection (PAI) | Blinding Assessment | POD7 | PAI | 6 Participants |
| Periarticular Injection (PAI) | Blinding Assessment | POD7 | EPCA | 6 Participants |
| Periarticular Injection (PAI) | Blinding Assessment | POD7 | PAI+EPCA | 17 Participants |
| Periarticular Injection (PAI) | Blinding Assessment | POD7 | Do Not Know | 17 Participants |
| Epidural Patient-Controlled Analg (EPCA) | Blinding Assessment | Discharge | PAI+EPCA | 11 Participants |
| Epidural Patient-Controlled Analg (EPCA) | Blinding Assessment | POD7 | PAI+EPCA | 16 Participants |
| Epidural Patient-Controlled Analg (EPCA) | Blinding Assessment | Discharge | Do Not Know | 18 Participants |
| Epidural Patient-Controlled Analg (EPCA) | Blinding Assessment | POD7 | PAI | 8 Participants |
| Epidural Patient-Controlled Analg (EPCA) | Blinding Assessment | POD7 | EPCA | 3 Participants |
| Epidural Patient-Controlled Analg (EPCA) | Blinding Assessment | Discharge | PAI | 13 Participants |
| Epidural Patient-Controlled Analg (EPCA) | Blinding Assessment | Discharge | EPCA | 10 Participants |
| Epidural Patient-Controlled Analg (EPCA) | Blinding Assessment | POD7 | Do Not Know | 18 Participants |
| PAI + EPCA | Blinding Assessment | Discharge | PAI+EPCA | 15 Participants |
| PAI + EPCA | Blinding Assessment | Discharge | EPCA | 6 Participants |
| PAI + EPCA | Blinding Assessment | Discharge | PAI | 7 Participants |
| PAI + EPCA | Blinding Assessment | Discharge | Do Not Know | 23 Participants |
| PAI + EPCA | Blinding Assessment | POD7 | PAI+EPCA | 13 Participants |
| PAI + EPCA | Blinding Assessment | POD7 | EPCA | 4 Participants |
| PAI + EPCA | Blinding Assessment | POD7 | PAI | 7 Participants |
| PAI + EPCA | Blinding Assessment | POD7 | Do Not Know | 18 Participants |
Secondary
Neuropathic Pain Assessed With S-LANSS
via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs). Scores range from 0-24. A lower score is a better outcome.
Time frame: Postoperative Day 7, Postoperative Day 90
Population: some patients were Lost to Follow up or did not answer questionnaire.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Periarticular Injection (PAI) | Neuropathic Pain Assessed With S-LANSS | POD7 | 8 score on a scale |
| Periarticular Injection (PAI) | Neuropathic Pain Assessed With S-LANSS | POD90 | 8 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Neuropathic Pain Assessed With S-LANSS | POD7 | 8 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Neuropathic Pain Assessed With S-LANSS | POD90 | 8 score on a scale |
| PAI + EPCA | Neuropathic Pain Assessed With S-LANSS | POD7 | 7.5 score on a scale |
| PAI + EPCA | Neuropathic Pain Assessed With S-LANSS | POD90 | 8 score on a scale |
Secondary
No Opioids Consumed
Number of patients who did not consume any opioids
Time frame: 0 to 24 hours post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Periarticular Injection (PAI) | No Opioids Consumed | 5 participants |
| Epidural Patient-Controlled Analg (EPCA) | No Opioids Consumed | 12 participants |
| PAI + EPCA | No Opioids Consumed | 14 participants |
Secondary
Opioid Consumption During the First 3 Days Post-op
Opioids consumed in the first 3 after surgery (cumulative consumption).
Time frame: Postoperative day 0,1,2,3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Periarticular Injection (PAI) | Opioid Consumption During the First 3 Days Post-op | 52.5 Oral Morphine Equivalent (mg) |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Consumption During the First 3 Days Post-op | 45 Oral Morphine Equivalent (mg) |
| PAI + EPCA | Opioid Consumption During the First 3 Days Post-op | 40 Oral Morphine Equivalent (mg) |
Secondary
Opioid Side Effects
via ORSDS (Opioid-Related Symptom Distress Scale). Each symptom was rated on a 4 point scale from 0-4. A lower score is a better outcome.
Time frame: Postoperative Day 1,2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Periarticular Injection (PAI) | Opioid Side Effects | POD2- Inability to Concentrate | 0.2 score on a scale | Standard Deviation 0.6 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD2- Nausea | 0.2 score on a scale | Standard Deviation 0.6 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD1- Nausea | 0.7 score on a scale | Standard Deviation 1.2 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD2-Dizziness | 0.4 score on a scale | Standard Deviation 0.8 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD2- Constipation | 0.7 score on a scale | Standard Deviation 1.1 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD1- Drowsiness | 1.1 score on a scale | Standard Deviation 1 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD1- Dizziness | 0.4 score on a scale | Standard Deviation 0.7 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD1- Constipation | 0.2 score on a scale | Standard Deviation 0.6 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD1- Fatigue | 0.8 score on a scale | Standard Deviation 1.2 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD2- Fatigue | 0.7 score on a scale | Standard Deviation 1 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD1- Inability to Concentrate | 0.2 score on a scale | Standard Deviation 0.6 |
| Periarticular Injection (PAI) | Opioid Side Effects | POD2- Drowsiness | 1 score on a scale | Standard Deviation 1 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD1- Inability to Concentrate | 0.1 score on a scale | Standard Deviation 0.5 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD2- Inability to Concentrate | 0.1 score on a scale | Standard Deviation 0.4 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD1- Fatigue | 0.6 score on a scale | Standard Deviation 0.9 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD1- Dizziness | 0.5 score on a scale | Standard Deviation 1 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD2- Nausea | 0.3 score on a scale | Standard Deviation 0.9 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD1- Drowsiness | 0.6 score on a scale | Standard Deviation 0.9 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD2- Fatigue | 0.7 score on a scale | Standard Deviation 1.1 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD2-Dizziness | 0.4 score on a scale | Standard Deviation 0.9 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD1- Nausea | 0.3 score on a scale | Standard Deviation 0.7 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD1- Constipation | 0.5 score on a scale | Standard Deviation 1 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD2- Constipation | 0.7 score on a scale | Standard Deviation 1.1 |
| Epidural Patient-Controlled Analg (EPCA) | Opioid Side Effects | POD2- Drowsiness | 0.7 score on a scale | Standard Deviation 1 |
| PAI + EPCA | Opioid Side Effects | POD2- Constipation | 1 score on a scale | Standard Deviation 1.3 |
| PAI + EPCA | Opioid Side Effects | POD1- Drowsiness | 1.3 score on a scale | Standard Deviation 1.1 |
| PAI + EPCA | Opioid Side Effects | POD1- Inability to Concentrate | 0.3 score on a scale | Standard Deviation 0.8 |
| PAI + EPCA | Opioid Side Effects | POD1- Nausea | 0.6 score on a scale | Standard Deviation 1 |
| PAI + EPCA | Opioid Side Effects | POD1- Dizziness | 0.9 score on a scale | Standard Deviation 1 |
| PAI + EPCA | Opioid Side Effects | POD1- Constipation | 0.4 score on a scale | Standard Deviation 0.8 |
| PAI + EPCA | Opioid Side Effects | POD2- Fatigue | 1 score on a scale | Standard Deviation 1.2 |
| PAI + EPCA | Opioid Side Effects | POD2- Drowsiness | 1.2 score on a scale | Standard Deviation 1.1 |
| PAI + EPCA | Opioid Side Effects | POD2- Inability to Concentrate | 0.3 score on a scale | Standard Deviation 0.8 |
| PAI + EPCA | Opioid Side Effects | POD2- Nausea | 0.6 score on a scale | Standard Deviation 1.1 |
| PAI + EPCA | Opioid Side Effects | POD2-Dizziness | 0.6 score on a scale | Standard Deviation 1.1 |
| PAI + EPCA | Opioid Side Effects | POD1- Fatigue | 0.9 score on a scale | Standard Deviation 1.1 |
Secondary
Pain at Rest
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Time frame: Postoperative Day 1,2,3,7,90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Periarticular Injection (PAI) | Pain at Rest | POD7 | 1.5 score on a scale | Standard Deviation 1.8 |
| Periarticular Injection (PAI) | Pain at Rest | POD3 | 1.8 score on a scale | Standard Deviation 1.6 |
| Periarticular Injection (PAI) | Pain at Rest | POD1 | 2 score on a scale | Standard Deviation 1.9 |
| Periarticular Injection (PAI) | Pain at Rest | POD2 | 2.2 score on a scale | Standard Deviation 2 |
| Periarticular Injection (PAI) | Pain at Rest | POD90 | 0.3 score on a scale | Standard Deviation 0.8 |
| Epidural Patient-Controlled Analg (EPCA) | Pain at Rest | POD3 | 1.2 score on a scale | Standard Deviation 1.5 |
| Epidural Patient-Controlled Analg (EPCA) | Pain at Rest | POD1 | 1.9 score on a scale | Standard Deviation 1.8 |
| Epidural Patient-Controlled Analg (EPCA) | Pain at Rest | POD2 | 1.8 score on a scale | Standard Deviation 1.9 |
| Epidural Patient-Controlled Analg (EPCA) | Pain at Rest | POD7 | 1.1 score on a scale | Standard Deviation 1.4 |
| Epidural Patient-Controlled Analg (EPCA) | Pain at Rest | POD90 | 0.3 score on a scale | Standard Deviation 0.7 |
| PAI + EPCA | Pain at Rest | POD90 | 0.6 score on a scale | Standard Deviation 1.3 |
| PAI + EPCA | Pain at Rest | POD7 | 1.5 score on a scale | Standard Deviation 1.7 |
| PAI + EPCA | Pain at Rest | POD1 | 1.7 score on a scale | Standard Deviation 1.8 |
| PAI + EPCA | Pain at Rest | POD3 | 1.3 score on a scale | Standard Deviation 1.4 |
| PAI + EPCA | Pain at Rest | POD2 | 1.9 score on a scale | Standard Deviation 1.8 |
Secondary
Pain With Activity
NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Time frame: Postoperative Day 1,2,3,7,90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Periarticular Injection (PAI) | Pain With Activity | POD7 | 2.8 score on a scale | Standard Deviation 2.1 |
| Periarticular Injection (PAI) | Pain With Activity | POD3 | 3.8 score on a scale | Standard Deviation 2.5 |
| Periarticular Injection (PAI) | Pain With Activity | POD1 | 3.6 score on a scale | Standard Deviation 2.4 |
| Periarticular Injection (PAI) | Pain With Activity | POD2 | 4.2 score on a scale | Standard Deviation 2.3 |
| Periarticular Injection (PAI) | Pain With Activity | POD90 | 0.7 score on a scale | Standard Deviation 1.2 |
| Epidural Patient-Controlled Analg (EPCA) | Pain With Activity | POD3 | 3.2 score on a scale | Standard Deviation 2.2 |
| Epidural Patient-Controlled Analg (EPCA) | Pain With Activity | POD1 | 3.4 score on a scale | Standard Deviation 2.3 |
| Epidural Patient-Controlled Analg (EPCA) | Pain With Activity | POD2 | 3.6 score on a scale | Standard Deviation 2.5 |
| Epidural Patient-Controlled Analg (EPCA) | Pain With Activity | POD7 | 2.7 score on a scale | Standard Deviation 1.9 |
| Epidural Patient-Controlled Analg (EPCA) | Pain With Activity | POD90 | 0.6 score on a scale | Standard Deviation 1.2 |
| PAI + EPCA | Pain With Activity | POD90 | 1.4 score on a scale | Standard Deviation 2.1 |
| PAI + EPCA | Pain With Activity | POD7 | 3 score on a scale | Standard Deviation 2 |
| PAI + EPCA | Pain With Activity | POD1 | 3.7 score on a scale | Standard Deviation 2.6 |
| PAI + EPCA | Pain With Activity | POD3 | 3.2 score on a scale | Standard Deviation 2.1 |
| PAI + EPCA | Pain With Activity | POD2 | 4 score on a scale | Standard Deviation 2.1 |
Secondary
Patient Satisfaction
via Likert scale. A higher score is a better outcome. the scale is from 0-10.
Time frame: Postoperative Day 1,2,3,7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Periarticular Injection (PAI) | Patient Satisfaction | POD7 | 9.6 score on a scale | Standard Deviation 0.9 |
| Periarticular Injection (PAI) | Patient Satisfaction | POD3 | 9.5 score on a scale | Standard Deviation 1 |
| Periarticular Injection (PAI) | Patient Satisfaction | POD1 | 9.6 score on a scale | Standard Deviation 1.3 |
| Periarticular Injection (PAI) | Patient Satisfaction | POD2 | 9.3 score on a scale | Standard Deviation 1.5 |
| Epidural Patient-Controlled Analg (EPCA) | Patient Satisfaction | POD3 | 9.1 score on a scale | Standard Deviation 1.5 |
| Epidural Patient-Controlled Analg (EPCA) | Patient Satisfaction | POD1 | 9.6 score on a scale | Standard Deviation 0.8 |
| Epidural Patient-Controlled Analg (EPCA) | Patient Satisfaction | POD2 | 9.1 score on a scale | Standard Deviation 1.5 |
| Epidural Patient-Controlled Analg (EPCA) | Patient Satisfaction | POD7 | 9.4 score on a scale | Standard Deviation 0.8 |
| PAI + EPCA | Patient Satisfaction | POD2 | 9.1 score on a scale | Standard Deviation 1.2 |
| PAI + EPCA | Patient Satisfaction | POD1 | 9.5 score on a scale | Standard Deviation 1.1 |
| PAI + EPCA | Patient Satisfaction | POD7 | 8.9 score on a scale | Standard Deviation 2.2 |
| PAI + EPCA | Patient Satisfaction | POD3 | 9.1 score on a scale | Standard Deviation 1.4 |
Secondary
Post-operative Pain
via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes.
Time frame: Postoperative Day 1
Population: some patients were lost to follow up or did not answer questionnaire.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Periarticular Injection (PAI) | Post-operative Pain | The worst pain you had in the last 24 hours | 5.5 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | The least pain you had in the last 24 hours | 0 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | How often were you in severe pain in the last 24 hours? | 1 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | How much pain interfered with doing activities in bed like turning, sitting up, changing position? | 1 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | How much pain interfered with or prevented you from breathing deeply or coughing? | 0 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | How much pain interfered with or prevented you from sleeping? | 0 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | How much pain interfered with doing activities out of bed? | 2 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | In the last 24 hours, have you had any nausea? | 0 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | In the last 24 hours, have you had any drowsiness? | 2.5 score on a scale |
| Periarticular Injection (PAI) | Post-operative Pain | In the last 24 hours, have you had any itching? | 0 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | In the last 24 hours, have you had any drowsiness? | 0 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | The worst pain you had in the last 24 hours | 5 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | How much pain interfered with or prevented you from sleeping? | 0 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | How much pain interfered with or prevented you from breathing deeply or coughing? | 0 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | The least pain you had in the last 24 hours | 0 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | In the last 24 hours, have you had any itching? | 0 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | In the last 24 hours, have you had any nausea? | 0 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | How often were you in severe pain in the last 24 hours? | 1 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | How much pain interfered with doing activities out of bed? | 2 score on a scale |
| Epidural Patient-Controlled Analg (EPCA) | Post-operative Pain | How much pain interfered with doing activities in bed like turning, sitting up, changing position? | 2 score on a scale |
| PAI + EPCA | Post-operative Pain | In the last 24 hours, have you had any nausea? | 0 score on a scale |
| PAI + EPCA | Post-operative Pain | How much pain interfered with doing activities in bed like turning, sitting up, changing position? | 1 score on a scale |
| PAI + EPCA | Post-operative Pain | How much pain interfered with or prevented you from breathing deeply or coughing? | 0 score on a scale |
| PAI + EPCA | Post-operative Pain | How much pain interfered with or prevented you from sleeping? | 0 score on a scale |
| PAI + EPCA | Post-operative Pain | In the last 24 hours, have you had any drowsiness? | 3 score on a scale |
| PAI + EPCA | Post-operative Pain | How much pain interfered with doing activities out of bed? | 2 score on a scale |
| PAI + EPCA | Post-operative Pain | The worst pain you had in the last 24 hours | 4 score on a scale |
| PAI + EPCA | Post-operative Pain | In the last 24 hours, have you had any itching? | 0 score on a scale |
| PAI + EPCA | Post-operative Pain | The least pain you had in the last 24 hours | 0 score on a scale |
| PAI + EPCA | Post-operative Pain | How often were you in severe pain in the last 24 hours? | 1 score on a scale |
Secondary
Quality of Recovery
Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome
Time frame: Postoperative Day 1,2,3
Population: Lost to follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Periarticular Injection (PAI) | Quality of Recovery | POD3 | 100.7 score on a scale | Standard Deviation 7 |
| Periarticular Injection (PAI) | Quality of Recovery | POD2 | 102.9 score on a scale | Standard Deviation 7.4 |
| Periarticular Injection (PAI) | Quality of Recovery | POD1 | 102.2 score on a scale | Standard Deviation 6.6 |
| Epidural Patient-Controlled Analg (EPCA) | Quality of Recovery | POD3 | 98.5 score on a scale | Standard Deviation 8.9 |
| Epidural Patient-Controlled Analg (EPCA) | Quality of Recovery | POD1 | 102.3 score on a scale | Standard Deviation 5.9 |
| Epidural Patient-Controlled Analg (EPCA) | Quality of Recovery | POD2 | 103.1 score on a scale | Standard Deviation 7.4 |
| PAI + EPCA | Quality of Recovery | POD3 | 98.4 score on a scale | Standard Deviation 8.8 |
| PAI + EPCA | Quality of Recovery | POD2 | 102.1 score on a scale | Standard Deviation 7.8 |
| PAI + EPCA | Quality of Recovery | POD1 | 101.6 score on a scale | Standard Deviation 6.8 |
Secondary
Readiness for Discharge Time
When patient meets all readiness for discharge criteria
Time frame: From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Periarticular Injection (PAI) | Readiness for Discharge Time | 46.5 hours |
| Epidural Patient-Controlled Analg (EPCA) | Readiness for Discharge Time | 48.7 hours |
| PAI + EPCA | Readiness for Discharge Time | 48.8 hours |