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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periarticular Injection (PAI) | Active Comparator |
|
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| Epidural Patient-Controlled Analg (EPCA) | Active Comparator |
|
|
| PAI + EPCA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periarticular injection (Deep injection) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | Oral morphine equivalents, cumulative | within 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Rest | NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome. | Postoperative Day 1,2,3,7,90 |
| Pain With Activity | NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kethy 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 | Periarticular Injection (PAI) |
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. |
| FG001 | Epidural Patient-Controlled Analg (EPCA) |
Bupivacaine: EPCA: Bupivacaine 0.06%. |
| FG002 | PAI + EPCA |
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%. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Periarticular Injection (PAI) |
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Opioid Use | Oral morphine equivalents, cumulative | Posted | Mean | Inter-Quartile Range | Oral Morphine Equivalent (mg) | within 24 hours after surgery |
|
3 months
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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 | Periarticular Injection (PAI) |
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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kethy Jules-Elysee | Hospital for Special Surgery | 2126061036 | JulesElyseeK@HSS.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2020 | May 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| Periarticular injection (Superficial injection) | Procedure | Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure. |
|
| Bupivacaine | Drug | EPCA: Bupivacaine 0.06%. |
|
| Placebo | Drug | EPCA: Saline. |
|
| Postoperative Day 1,2,3,7,90 |
| 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. | Postoperative Day 1,2 |
| Patient Satisfaction | via Likert scale. A higher score is a better outcome. the scale is from 0-10. | Postoperative Day 1,2,3,7 |
| Post-operative Pain | via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes. | Postoperative Day 1 |
| 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. | Postoperative Day 7, Postoperative Day 90 |
| Quality of Recovery | Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome | Postoperative Day 1,2,3 |
| Readiness for Discharge Time | When patient meets all readiness for discharge criteria | From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week. |
| Blinding Assessment | What group do you think you were in | Assessed on day of discharge and on seventh post operative day |
| Opioid Consumption During the First 3 Days Post-op | Opioids consumed in the first 3 after surgery (cumulative consumption). | Postoperative day 0,1,2,3 |
| No Opioids Consumed | Number of patients who did not consume any opioids | 0 to 24 hours post-operatively |
| Epidural catheter could not be placed |
|
| BG001 | Epidural Patient-Controlled Analg (EPCA) |
Bupivacaine: EPCA: Bupivacaine 0.06%. |
| BG002 | PAI + EPCA |
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%. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Epidural Patient-Controlled Analg (EPCA) |
Bupivacaine: EPCA: Bupivacaine 0.06%. |
| OG002 | PAI + EPCA |
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%. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 1,2,3,7,90 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 1,2,3,7,90 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 1,2 |
|
|
|
| Secondary | Patient Satisfaction | via Likert scale. A higher score is a better outcome. the scale is from 0-10. | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 1,2,3,7 |
|
|
|
| Secondary | Post-operative Pain | via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes. | some patients were lost to follow up or did not answer questionnaire. | Posted | Median | Inter-Quartile Range | score on a scale | Postoperative Day 1 |
|
|
|
| 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. | some patients were Lost to Follow up or did not answer questionnaire. | Posted | Median | Inter-Quartile Range | score on a scale | Postoperative Day 7, Postoperative Day 90 |
|
|
|
| Secondary | Quality of Recovery | Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome | Lost to follow up | Posted | Mean | Standard Deviation | score on a scale | Postoperative Day 1,2,3 |
|
|
|
| Secondary | Readiness for Discharge Time | When patient meets all readiness for discharge criteria | Posted | Median | Inter-Quartile Range | hours | From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week. |
|
|
|
| Secondary | Blinding Assessment | What group do you think you were in | Lost to follow up | Posted | Count of Participants | Participants | Assessed on day of discharge and on seventh post operative day |
|
|
|
| Secondary | Opioid Consumption During the First 3 Days Post-op | Opioids consumed in the first 3 after surgery (cumulative consumption). | Posted | Median | Inter-Quartile Range | Oral Morphine Equivalent (mg) | Postoperative day 0,1,2,3 |
|
|
|
| Secondary | No Opioids Consumed | Number of patients who did not consume any opioids | Posted | Number | participants | 0 to 24 hours post-operatively |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Epidural Patient-Controlled Analg (EPCA) |
Bupivacaine: EPCA: Bupivacaine 0.06%. | 0 | 60 | 0 | 60 | 0 | 60 |
| EG002 | PAI + EPCA |
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%. | 0 | 60 | 0 | 60 | 0 | 60 |
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| D012216 |
| Rheumatic Diseases |
| D000588 |
| Amines |
|
| POD3 |
|
| POD7 |
|
| POD90 |
|
|
| POD3 |
|
| POD7 |
|
| POD90 |
|
|
| POD1- Inability to Concentrate |
|
| POD1- Nausea |
|
| POD1- Dizziness |
|
| POD1- Constipation |
|
| POD2- Fatigue |
|
| POD2- Drowsiness |
|
| POD2- Inability to Concentrate |
|
| POD2- Nausea |
|
| POD2-Dizziness |
|
| POD2- Constipation |
|
|
| POD3 |
|
| POD7 |
|
|
| How often were you in severe pain in the last 24 hours? |
|
| How much pain interfered with doing activities in bed like turning, sitting up, changing position? |
|
| How much pain interfered with or prevented you from breathing deeply or coughing? |
|
| How much pain interfered with or prevented you from sleeping? |
|
| How much pain interfered with doing activities out of bed? |
|
| In the last 24 hours, have you had any nausea? |
|
| In the last 24 hours, have you had any drowsiness? |
|
| In the last 24 hours, have you had any itching? |
|
| POD90 |
|
|
| POD2 |
|
|
| POD3 |
|
|
| EPCA |
|
| PAI+EPCA |
|
| Do Not Know |
|
| POD7 |
|
|