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The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee arthroplasty can be observed with the substitution of a post operative adductor canal block for a preoperative adductor canal block in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Adductor Canal Block Group | Active Comparator | Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery. |
|
| Postoperative Adductor Canal Block Group | Experimental | Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Status as Measured by Numeric Pain Scale | Scale with numeric scores ranging from 0 (least) to 10 (most) pain | 2 hours postoperatively |
| Pain Status as Measured by Numeric Pain Scale | Scale with numeric scores ranging from 0 (least) to 10 (most) pain | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Reporting Nausea | Count of the number of patients reporting nausea | 2 hours postoperatively |
| Episodes of Nausea | Count of the number of episodes of nausea per patient |
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Inclusion Criteria:
1- Patients 18 or older 2 - Patients undergoing primary total knee replacement at the University of Miami Hospital 3 - Patients that have capacity to provide medical consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor H. Hernandez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative Adductor Canal Block Group | Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery. Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. |
| FG001 | Postoperative Adductor Canal Block Group | Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of individual patients in the respective group
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative Adductor Canal Block Group | Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery. Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Status as Measured by Numeric Pain Scale | Scale with numeric scores ranging from 0 (least) to 10 (most) pain | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | score on a scale | 2 hours postoperatively |
|
24 hours postoperatively
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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 | Preoperative Adductor Canal Block Group | Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery. Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Victor H. Hernandez | University of Miami | 305-243-4000 | vhh1@med.miami.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 | Jan 13, 2025 | Jan 18, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000082 | Acetaminophen |
| D000069583 | Pregabalin |
| D000068579 | Celecoxib |
| D000077239 | Meloxicam |
| D010098 | Oxycodone |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Acetaminophen | Drug | 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively |
|
| Lyrica | Drug | Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively |
|
| Celebrex | Drug | 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively |
|
| Meloxicam | Drug | 30mg administered via IV once postoperatively within 24 hours for pain and swelling |
|
| Oxycodone | Drug | 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively |
|
| Ropivacaine | Drug | 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. |
|
|
| 2 hours postoperatively |
| Patients Reporting Nausea | Count of the number of patients reporting nausea | 24 hours postoperatively |
| Episodes of Nausea | Count of the number of episodes of nausea per patient | 24 hours postoperatively |
| Patients Reporting Vomiting | Count of the number of patients reporting vomiting | 2 hours postoperatively |
| Episodes of Vomiting | Count of the number of episodes of vomiting per patient | 2 hours postoperatively |
| Patients Reporting Vomiting | Count of the number of patients reporting vomiting | 24 hours postoperatively |
| Episodes of Vomiting | Count of the number of episodes of vomiting per patient | 24 hours postoperatively |
| Total Opioid Consumption | Measure of the amount of morphine milliequivalents consumed by the patient | 2 hours postoperatively |
| Total Opioid Consumption | Measure of the amount of morphine milliequivalents consumed by the patient | 24 hours postoperatively |
| Nights Hospitalized | Number of nights hospitalized | Up to 14 nights postoperatively |
| Hours Hospitalized | Number of hours hospitalized | Up to 336 hours postoperatively |
| Discharges by Midnight POD0 | The number of patients discharged home by midnight on postoperative day zero | Up to 24 hours postoperatively |
| Discharges by Midnight on POD1 | The number of patients discharged home by midnight postoperative day one | Up to 48 hours postoperatively |
| BG001 | Postoperative Adductor Canal Block Group | Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Median | Standard Deviation | kg/m^2 |
|
| OG001 | Postoperative Adductor Canal Block Group | Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. |
|
|
| Primary | Pain Status as Measured by Numeric Pain Scale | Scale with numeric scores ranging from 0 (least) to 10 (most) pain | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | score on a scale | 24 hours postoperatively |
|
|
|
| Secondary | Patients Reporting Nausea | Count of the number of patients reporting nausea | Patients who completed the study in one of the two groups | Posted | Count of Participants | Participants | 2 hours postoperatively |
|
|
|
| Secondary | Episodes of Nausea | Count of the number of episodes of nausea per patient | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | number of episodes per patient | 2 hours postoperatively |
|
|
|
| Secondary | Patients Reporting Nausea | Count of the number of patients reporting nausea | Patients who completed the study in one of the two groups | Posted | Count of Participants | Participants | 24 hours postoperatively |
|
|
|
| Secondary | Episodes of Nausea | Count of the number of episodes of nausea per patient | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | number of episodes per patient | 24 hours postoperatively |
|
|
|
| Secondary | Patients Reporting Vomiting | Count of the number of patients reporting vomiting | Patients who completed the study in one of the two groups | Posted | Count of Participants | Participants | 2 hours postoperatively |
|
|
|
| Secondary | Episodes of Vomiting | Count of the number of episodes of vomiting per patient | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | number of episodes per patient | 2 hours postoperatively |
|
|
|
| Secondary | Patients Reporting Vomiting | Count of the number of patients reporting vomiting | Patients who completed the study in one of the two groups | Posted | Count of Participants | Participants | 24 hours postoperatively |
|
|
|
| Secondary | Episodes of Vomiting | Count of the number of episodes of vomiting per patient | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | number of episodes per patient | 24 hours postoperatively |
|
|
|
| Secondary | Total Opioid Consumption | Measure of the amount of morphine milliequivalents consumed by the patient | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | milligram morphine equivalents | 2 hours postoperatively |
|
|
|
| Secondary | Total Opioid Consumption | Measure of the amount of morphine milliequivalents consumed by the patient | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | milligram morphine equivalents | 24 hours postoperatively |
|
|
|
| Secondary | Nights Hospitalized | Number of nights hospitalized | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | nights | Up to 14 nights postoperatively |
|
|
|
| Secondary | Hours Hospitalized | Number of hours hospitalized | Patients who completed the study in one of the two groups | Posted | Median | 95% Confidence Interval | hours | Up to 336 hours postoperatively |
|
|
|
| Secondary | Discharges by Midnight POD0 | The number of patients discharged home by midnight on postoperative day zero | Patients who completed the study in one of the two groups | Posted | Count of Participants | Participants | Up to 24 hours postoperatively |
|
|
|
| Secondary | Discharges by Midnight on POD1 | The number of patients discharged home by midnight postoperative day one | Patients who completed the study in one of the two groups | Posted | Count of Participants | Participants | Up to 48 hours postoperatively |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Postoperative Adductor Canal Block Group | Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours Dexamethasone: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling Acetaminophen: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively Lyrica: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively Celebrex: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively Meloxicam: 30mg administered via IV once postoperatively within 24 hours for pain and swelling Oxycodone: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively Ropivacaine: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively. | 0 | 38 | 0 | 38 | 0 | 38 |
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| D012216 |
| Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013843 | Thiazines |
| D013844 | Thiazoles |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |