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The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTX-011 Treatment Group | Experimental | Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia |
|
| Standard Block Control Group | Active Comparator | Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTX-011 | Drug | Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Control at 72 Hours Postoperatively | Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within 72 hours. The maximum value would be 720, meaning patients reported a 10 for pain on a 0-10 scale at all 15 time points within 72 hours. | 72-hours postoperatively after total knee arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Control at 48 Hours Postoperatively | Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-48 hours) / NRS AUC 0-48. Pain scores were collected by patient self-report 11 times over the 48 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 48 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 11 time points within 48 hours. The maximum value would be 480, meaning patients reported a 10 for pain on a 0-10 scale at all 11 time points within 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew P Abdel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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An initial pilot of 18 patients ran from 3/11/2022 to 8/30/2022 after which a protocol change caused these patients to be withdrawn and not assigned to a treatment arm in the final study count. One additional patient was withdrawn prior to randomization as allergy results returned which excluded participation.
Recruitment for this study ran from 3/11/2022 until 4/9/2024 when the final patient was enrolled. Patients were enrolled from the Orthopedic clinical practice at Mayo Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | HTX-011 Treatment Group | Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia HTX-011: Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution |
| FG001 | Standard Block Control Group | Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia ropivacaine , epinephrine , ketorolac diluted in sodium chloride: Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HTX-011 Treatment Group | Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia HTX-011: Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution |
| BG001 | Standard Block Control Group |
| 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 Control at 72 Hours Postoperatively | Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-72 hours) / NRS AUC 0-72. Pain scores were collected by patient self-report 15 times over the 72 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 72 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 15 time points within 72 hours. The maximum value would be 720, meaning patients reported a 10 for pain on a 0-10 scale at all 15 time points within 72 hours. | Posted | Mean | Standard Deviation | score on a scale * hours | 72-hours postoperatively after total knee arthroplasty |
|
Adverse event data was collected from patient consent until 72 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 | HTX-011 Treatment Group | Subjects undergoing a total knee arthroplasty will receive HTX-011 (Zynrelef) for perioperative analgesia HTX-011: Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Stomach distress or discomfort with a possible urge to vomit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Schouten - Clinical Research Coordinator | Mayo Clinic | 507-266-5895 | schouten.gabriel@mayo.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 29, 2024 | Mar 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000723006 | bupivacaine-meloxicam drug combination |
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| ropivacaine , epinephrine , ketorolac diluted in sodium chloride | Drug | Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride |
|
|
| 48-hours postoperative total knee arthroplasty |
| Opioid Consumption 72 Hours Postoperatively | Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs) | 72-hours postoperative total knee arthroplasty |
| Opioid Consumption 48 Hours Postoperatively | Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs) | 48 hours postoperative total knee arthroplasty |
| Physician Decision |
|
| Withdrawal by Subject |
|
Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia ropivacaine , epinephrine , ketorolac diluted in sodium chloride: Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride |
| 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 |
|
| OG001 | Standard Block Control Group | Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia ropivacaine , epinephrine , ketorolac diluted in sodium chloride: Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride |
|
|
|
| Secondary | Pain Control at 48 Hours Postoperatively | Area Under the Curve (AUC) of the graph for mean Numerical Rated Score (NRS) for pain (0-10) over time (0-48 hours) / NRS AUC 0-48. Pain scores were collected by patient self-report 11 times over the 48 hours after surgery, and averaged amongst the patients for each study arm. Lower values represent better pain control based on lower mean 0-10 pain scores over the 48 hour period after surgery. The minimum value is 0, meaning patients reported 0 pain on a 0-10 scale at all 11 time points within 48 hours. The maximum value would be 480, meaning patients reported a 10 for pain on a 0-10 scale at all 11 time points within 48 hours | Posted | Mean | Standard Deviation | score on a scale * hours | 48-hours postoperative total knee arthroplasty |
|
|
|
| Secondary | Opioid Consumption 72 Hours Postoperatively | Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs) | patient who returned a complete pain diary | Posted | Mean | Full Range | MME | 72-hours postoperative total knee arthroplasty |
|
|
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| Secondary | Opioid Consumption 48 Hours Postoperatively | Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs) | patients who returned a completed pain diary | Posted | Mean | Full Range | MME | 48 hours postoperative total knee arthroplasty |
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| 0 |
| 53 |
| 0 |
| 53 |
| 1 |
| 53 |
| EG001 | Standard Block Control Group | Subjects undergoing a total knee arthroplasty will receive standard of care arthroplasty block for perioperative analgesia ropivacaine , epinephrine , ketorolac diluted in sodium chloride: Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride | 0 | 48 | 0 | 48 | 2 | 48 |
|
| Seizure | Nervous system disorders | Non-systematic Assessment | A sudden burst of electrical activity in the brain possibly causing changes in behavior, movements, feelings and levels of consciousness |
|
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| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |