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The goal of this clinical trial is to determine whether Periarticular Injection (PAI) alongside Adductor Canal Block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block can decrease post-operative pain in patients undergoing primary total knee arthroplasty. The main question it aims to answer is:
• Is ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients?
Participants will be assigned to one of the following groups at random:
Participants will also be asked to complete pre- and post-operative questionnaires.
Kim et al (2019) have shown that addition of ACB/IPACK to PAI improves analgesic outcomes (the nerve blocks reduced pain with ambulation and reduced opioid consumption). TKA patients receiving PAI + ACB/IPACK (along with a comprehensive multimodal analgesic program) had low pain scores with ambulation on POD1: 1.7 +/- 1.4 (mean +/- SD, NRS, 0-10 scale). The opioid consumption in the first 24 hours was 40.6 +/- 32.1 (mg oral morphine equivalents).
It is not clear if the PAI component is necessary, given the theoretically nearly complete analgesic effects of the ACB/IPACK block. Additionally, anecdotal evidence indicates that some surgeons at HSS routinely use the PAI and some do not, without obvious large differences in analgesic outcomes. While there may be a 'belt and suspenders' advantage to using PAI in addition to ACB/IPACK, it is not desirable to perform unnecessary procedures.
In this study, we seek to compare the efficacy of ACB/IPACK with and without PAI in TKA patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No PAI + ACB & IPACK | Placebo Comparator | Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline) |
|
| PAI + ACB & IPACK | Active Comparator | Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periarticular Injection (PAI) | Drug | PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores (NRS, 0-10) With Ambulation on POD1 | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1. | 24 hours Post Operative Discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge, 24h post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge. | post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques YaDeau, MD, PhD | 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 |
Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an Independent review committee ("learned intermediary") identified for this purpose and who have signed a DUA.
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| ID | Title | Description |
|---|---|---|
| FG000 | No PAI + ACB & IPACK | Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline) Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections |
| FG001 | PAI + ACB & IPACK | Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No PAI + ACB & IPACK | Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline) Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections |
| BG001 | PAI + ACB & IPACK |
| 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 | Pain Scores (NRS, 0-10) With Ambulation on POD1 | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1. | Posted | Mean | Standard Deviation | units on a scale | 24 hours Post Operative Discharge |
|
Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).
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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 | No PAI + ACB & IPACK | Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline) Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| leakage at the incision site | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justas Lauzadis, PhD | Hospital for Special Surgery | 212-774-2946 | lauzadisj@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 | Apr 14, 2022 | Feb 13, 2024 | Prot_SAP_000.pdf |
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| Saline Control Periarticular Injection (PAI) | Drug | equal volume of saline will be used in place of analgesics used in PAI injections |
|
| NRS Pain With Movement | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain during movement and will be asked at pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months. | pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months |
| Numerical Rating Scale (NRS) Pain Score at Rest | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain without movement involved and will be asked at pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months | from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months |
| PAIN OUT Questionnaire at Preoperation | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. | at preoperation |
| Quality of Recovery (POD1) | Quality of Recovery (QoR-9), This questionnaire has three options for scale (not at all, some of the time, most of the time). The QoR-9 is a nine-item scale. Total QoR-9-scores range from 0 to 18, with higher scores indicating good recovery after anaesthesia. The questions focus on the overall well being of the patient. The questionnaire will be asked 24 hours post surgical discharge. | 24 hours post surgical discharge. |
| Side Effects: Opioid-Related Symptom Distress Score (POD1) | The Opioid-related symptom distress scale evaluates frequency, severity, bothersomeness for 12 symptoms. Each symptom is scored on a 4-point scale, with 0 meaning better outcome and 4 meaning worst outcome. The questionnaire will be asked 24 hours (POD 1) post surgical discharge. | 24 hours (POD 1) post surgical discharge. |
| Satisfaction With Pain Management (POD1) | This questionnaire is a numeric scale from 0 (strongly dissatisfied) to 10 ( strongly satisfied). A higher number dictates a better outcome. This will be asked 24 hours post operative discharge. | 24 hours post operative discharge. |
| Blinding Assessment; Bang Question (POD1) | There is no numeric scale for this questionnaire. It focuses on asking the subjects and the research assistant, which group they believe the subject were randomized to. This will be asked 24 hours post operative discharge. | 24 hours post operative discharge |
| Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months | The DN4 ( Douleur Neuropathique en 4 Questions) is a Yes/No questionnaire aimed at uncovering neuropathic pain symptoms. Each question is scored as yes or no, with yes = 1 point and no = 0 points. Total score is calculated by summing the total of the individual question scores, for a total score range of 0-10, with a score of greater than or equal to 4 indicating the patient may be suffering from neuropathic pain. The average score across all participants is calculated and reported for each time point. | Pre operative, 3 months post operative discharge. |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | The standard Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.) questionnaire will be asked to evaluate orthopedic outcomes. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. The questionnaire will be asked preoperatively, 6 weeks post operative discharge, 3 months post operative discharge. | preoperatively, 6 weeks post operative discharge, 3 months post operative discharge |
| PAIN OUT Questionnaire at Post Operative Day (POD) 1 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. | at post operative day (POD) 1 |
| PAIN OUT Questionnaire at Post Operative Day (POD) 14 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. | at post operative day (POD) 14 |
| PAIN OUT Questionnaire at Post Operative Day (POD) 90 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. | at post operative day (POD) 90 |
| PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. | at preoperation |
| PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. | at post operative day (POD) 1 |
| PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. | at post operative day (POD) 14 |
| PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. | at post operative day (POD) 90 |
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients. |
| BG002 | 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 |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologists Status | The grade is on a scale of 1-4 and is based on the patient's medical history, severity of known medical conditions, and current physical state to help predict if they can tolerate anesthesia and the conditions of surgery. | Count of Participants | Participants |
|
|
|
|
| Secondary | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge, 24h post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge. | At post operative day 14 and 90, the number analyzed differ from the overall number because some subjects were lost to follow up. | Posted | Mean | Standard Deviation | MME/day | post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge. |
|
|
|
|
| Secondary | NRS Pain With Movement | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain during movement and will be asked at pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months. | the number of participants analyzed at POD 3 months is different due to lost to follow ups | Posted | Mean | Standard Deviation | units on a scale | pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months |
|
|
|
| Secondary | Numerical Rating Scale (NRS) Pain Score at Rest | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain without movement involved and will be asked at pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months | number of participants analyzed at POD 3 months differed from overall number of participants due to lost to follow up | Posted | Mean | Standard Deviation | units on a scale | from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months |
|
|
|
| Secondary | PAIN OUT Questionnaire at Preoperation | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | at preoperation |
|
|
|
| Secondary | Quality of Recovery (POD1) | Quality of Recovery (QoR-9), This questionnaire has three options for scale (not at all, some of the time, most of the time). The QoR-9 is a nine-item scale. Total QoR-9-scores range from 0 to 18, with higher scores indicating good recovery after anaesthesia. The questions focus on the overall well being of the patient. The questionnaire will be asked 24 hours post surgical discharge. | Posted | Mean | Standard Deviation | units on a scale | 24 hours post surgical discharge. |
|
|
|
| Secondary | Side Effects: Opioid-Related Symptom Distress Score (POD1) | The Opioid-related symptom distress scale evaluates frequency, severity, bothersomeness for 12 symptoms. Each symptom is scored on a 4-point scale, with 0 meaning better outcome and 4 meaning worst outcome. The questionnaire will be asked 24 hours (POD 1) post surgical discharge. | Posted | Mean | Standard Deviation | score on a scale | 24 hours (POD 1) post surgical discharge. |
|
|
|
| Secondary | Satisfaction With Pain Management (POD1) | This questionnaire is a numeric scale from 0 (strongly dissatisfied) to 10 ( strongly satisfied). A higher number dictates a better outcome. This will be asked 24 hours post operative discharge. | Posted | Mean | Standard Deviation | score on a scale | 24 hours post operative discharge. |
|
|
|
| Secondary | Blinding Assessment; Bang Question (POD1) | There is no numeric scale for this questionnaire. It focuses on asking the subjects and the research assistant, which group they believe the subject were randomized to. This will be asked 24 hours post operative discharge. | Posted | Count of Participants | Participants | 24 hours post operative discharge |
|
|
|
| Secondary | Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months | The DN4 ( Douleur Neuropathique en 4 Questions) is a Yes/No questionnaire aimed at uncovering neuropathic pain symptoms. Each question is scored as yes or no, with yes = 1 point and no = 0 points. Total score is calculated by summing the total of the individual question scores, for a total score range of 0-10, with a score of greater than or equal to 4 indicating the patient may be suffering from neuropathic pain. The average score across all participants is calculated and reported for each time point. | The number analyzed at POD 3 months differs from the overall number of participant due to lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Pre operative, 3 months post operative discharge. |
|
|
|
| Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | The standard Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.) questionnaire will be asked to evaluate orthopedic outcomes. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. The questionnaire will be asked preoperatively, 6 weeks post operative discharge, 3 months post operative discharge. | The number analyzed at 6 weeks and 3 months differ from the overall number due to lost to follow up | Posted | Mean | Standard Deviation | score on a scale | preoperatively, 6 weeks post operative discharge, 3 months post operative discharge |
|
|
|
| Secondary | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | at post operative day (POD) 1 |
|
|
|
| Secondary | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | at post operative day (POD) 14 |
|
|
|
| Secondary | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | at post operative day (POD) 90 |
|
|
|
| Secondary | PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. | preoperative | Posted | Mean | Standard Deviation | percentage of time or relief | at preoperation |
|
|
|
| Secondary | PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. | Posted | Mean | Standard Deviation | percentage of time or relief | at post operative day (POD) 1 |
|
|
|
| Secondary | PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. | Posted | Mean | Standard Deviation | percentage of time or relief | at post operative day (POD) 14 |
|
|
|
| Secondary | PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. | Posted | Mean | Standard Deviation | percentage of time or relief | at post operative day (POD) 90 |
|
|
|
| 0 |
| 47 |
| 1 |
| 47 |
| 0 |
| 47 |
| EG001 | PAI + ACB & IPACK | Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients. | 0 | 47 | 2 | 47 | 0 | 47 |
| postoperative myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| postoperative reduced range of motion | Surgical and medical procedures | Non-systematic Assessment | postoperative reduced range of motion requiring a knee manipulation |
|
Not provided
Not provided
Not provided
| post operative day (POD) 1 |
|
|
| post operative day (POD) 2 |
|
|
| post operative day (POD) 14 |
|
|
| post operative day (POD) 90 |
|
|
| Post anesthesia care unit (PACU) |
|
|
| Post operative day (POD) 1 |
|
|
| Post operative day (POD) 2 |
|
|
| Post operative day (POD) 3 months |
|
|
| post anesthesia care unit (PACU) |
|
|
| post operative day (POD) 1 |
|
|
| post operative day (POD) 2 |
|
|
| post operative day (POD) 3 months |
|
|
| Pain interfered or prevented you from activities in bed |
|
| Pain interfered or prevented you from activities out of bed |
|
| Pain interfered or prevented you from falling asleep |
|
| Pain interfered or prevented you from staying asleep |
|
| How much the pain caused you to feel anxious |
|
| How much the pain caused you to feel depressed |
|
| How much the pain caused you to feel frightened |
|
| How much the pain caused you to feel helpless |
|
| Severity of nausea |
|
| Severity of drowsiness |
|
| Severity of itching |
|
| Severity of dizziness |
|
| Were you allowed to participate in decisions about pain treatment? |
|
| How satisfied are you with the results of your pain treatment? |
|
| Guessed "Don't know" |
|
| Research Assistant Guess |
|
| post operative day (POD) 3 months |
|
|
| at 6 weeks |
|
|
| at 3 months |
|
|
| Pain interfered or prevented you from activities in bed |
|
| Pain interfered or prevented you from activities out of bed |
|
| Pain interfered or prevented you from falling asleep |
|
| Pain interfered or prevented you from staying asleep |
|
| How much the pain caused you to feel anxious |
|
| How much the pain caused you to feel depressed |
|
| How much the pain caused you to feel frightened |
|
| How much the pain caused you to feel helpless |
|
| Severity of nausea |
|
| Severity of drowsiness |
|
| Severity of itching |
|
| Severity of dizziness |
|
| Were you allowed to participate in decisions about pain treatment? |
|
| How satisfied are you with the results of your pain treatment? |
|
| Pain interfered or prevented you from activities in bed |
|
| Pain interfered or prevented you from activities out of bed |
|
| Pain interfered or prevented you from falling asleep |
|
| Pain interfered or prevented you from staying asleep |
|
| How much the pain caused you to feel anxious |
|
| How much the pain caused you to feel depressed |
|
| How much the pain caused you to feel frightened |
|
| How much the pain caused you to feel helpless |
|
| Severity of nausea |
|
| Severity of drowsiness |
|
| Severity of itching |
|
| Severity of dizziness |
|
| Were you allowed to participate in decisions about pain treatment? |
|
| How satisfied are you with the results of your pain treatment? |
|
| Pain interfered or prevented you from activities in bed |
|
| Pain interfered or prevented you from activities out of bed |
|
| Pain interfered or prevented you from falling asleep |
|
| Pain interfered or prevented you from staying asleep |
|
| How much the pain caused you to feel anxious |
|
| How much the pain caused you to feel depressed |
|
| How much the pain caused you to feel frightened |
|
| How much the pain caused you to feel helpless |
|
| Severity of nausea |
|
| Severity of drowsiness |
|
| Severity of itching |
|
| Severity of dizziness |
|
| Were you allowed to participate in decisions about pain treatment? |
|
| How satisfied are you with the results of your pain treatment? |
|