Acute Postoperative Pain
Conditions
Keywords
postoperative pain, post-surgical pain total knee arthroplasty, total knee replacement ATX-101, bupivacaine, bupivacaine implant
Brief summary
This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty. The following is short title and acronym for the study: Study Assessing Pain Relief after Replacement of the Knee (SPARK)
Interventions
DRUGATX-101
ATX-101 (bupivacaine) implant, one-time administration into the surgical site
DRUGbupivacaine hydrochloride without epinephrine
bupivacaine hydrochloride (125 mg) without epinephrine via local infiltration and/or nerve block
Sponsors
Allay Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a Phase 2B, randomized, double blind, active comparator multicenter trial in participants undergoing total knee arthroplasty.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis. * Scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted). * American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2 or 3.
Exclusion criteria
* Has a planned concurrent surgical procedure. * Has had any previous arthroplasty, unicompartmental knee arthroplasty or total knee arthroplasty in the study knee or previous arthroplasty, unicompartmental knee arthroplasty, or total knee arthroplasty in the contralateral knee within 6 months prior to screening. * Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee. * Immunocompromised or has a known history of Hepatitis B, human immunodeficiency virus (HIV), or Hepatitis C. * Routinely take opioid analgesics and are expected to require opioid analgesics in the postsurgical period that is not strictly related to the trial. * Unable to abstain from opioid use for knee pain within 14 days of surgery. * Has been administered systemic steroids within 14 days prior to surgery. * Has been administered any local anesthetic within 5 days prior to the scheduled surgery. * Screening electrocardiogram (ECG) with significant abnormalities associated with significant heart disease. * Has a contraindication or a known suspected history of allergy, hypersensitivity or idiosyncratic reaction to trial medications. * Has uncontrolled depression, anxiety, psychiatric, or neurological disorder that might interfere with trial study assessments. * Has a medical condition or receiving medication such that, in the opinion of the investigator, participating in the trial would pose a health risk to the subject or might interfere with the study outcome. * Has a known or suspected history of drug or alcohol abuse. A subject with a history of alcohol use disorder that has ≥10 years sobriety will be permitted. * Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine. * Has a Body Mass Index (BMI) ≥45 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity. | from 30 minutes post-surgery through hour 168 (Day 8) | NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subject Who Remain Opioid Free. | Surgical Closure to Day 30 | Opioid free is defined as no opioid rescue medication was recorded for the timepoint displayed and onwards. |
| Total Post-surgical Use of Rescue Opioid Medications. | Surgical Closure to Day 30, Opioid consumption is summarized descriptively every 24-hour period through Day 30 | Total post-surgical use of rescue opioid medications (days). |
| Time to First Rescue Opioid Medication. | Surgical Closure to Day 30 | Time to first postsurgical use of rescue opioid medication (days). |
Countries
Australia, Canada, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ATX-101 1000 mg ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site | 37 |
| ATX-101 1500 mg ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site | 37 |
| Bupivacaine Hydrochloride bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block | 34 |
| Saline Placebo Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration | 4 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | ATX-101 1000 mg | ATX-101 1500 mg | Bupivacaine Hydrochloride | Saline Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 22 Participants | 20 Participants | 2 Participants | 66 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 14 Participants | 2 Participants | 46 Participants |
| Age, Continuous | 68.2 years STANDARD_DEVIATION 8.12 | 68.3 years STANDARD_DEVIATION 6.89 | 67.5 years STANDARD_DEVIATION 7.62 | 63.0 years STANDARD_DEVIATION 12.38 | 67.8 years STANDARD_DEVIATION 7.69 |
| Body Mass Index (BMI) | 30.39 kg/m2 STANDARD_DEVIATION 4.473 | 31.20 kg/m2 STANDARD_DEVIATION 5.131 | 33.01 kg/m2 STANDARD_DEVIATION 5.185 | 29.58 kg/m2 STANDARD_DEVIATION 1.431 | 31.42 kg/m2 STANDARD_DEVIATION 4.934 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 35 Participants | 31 Participants | 32 Participants | 4 Participants | 102 Participants |
| Region of Enrollment Australia | 20 participants | 21 participants | 14 participants | 4 participants | 59 participants |
| Region of Enrollment Canada | 7 participants | 6 participants | 7 participants | 0 participants | 20 participants |
| Region of Enrollment United Kingdom | 10 participants | 10 participants | 13 participants | 0 participants | 33 participants |
| Sex: Female, Male Female | 20 Participants | 19 Participants | 22 Participants | 2 Participants | 63 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 12 Participants | 2 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 | 0 / 34 | 0 / 4 |
| other Total, other adverse events | 30 / 37 | 25 / 37 | 28 / 34 | 4 / 4 |
| serious Total, serious adverse events | 3 / 37 | 4 / 37 | 2 / 34 | 0 / 4 |
Outcome results
Primary
Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity.
NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
Time frame: from 30 minutes post-surgery through hour 168 (Day 8)
Population: Full analysis set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATX-101 1000 mg | Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity. | 517.32 pain intensity score*hour | Standard Deviation 284.675 |
| ATX-101 1500 mg | Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity. | 518.03 pain intensity score*hour | Standard Deviation 239.299 |
| Bupivacaine Hydrochloride | Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity. | 595.26 pain intensity score*hour | Standard Deviation 258.945 |
| Saline Placebo | Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity. | 756.84 pain intensity score*hour | Standard Deviation 261.454 |
Secondary
Percentage of Subject Who Remain Opioid Free.
Opioid free is defined as no opioid rescue medication was recorded for the timepoint displayed and onwards.
Time frame: Surgical Closure to Day 30
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ATX-101 1000 mg | Percentage of Subject Who Remain Opioid Free. | Surgical Closure - Day 30 | 3 Participants |
| ATX-101 1000 mg | Percentage of Subject Who Remain Opioid Free. | Day 4 - Day 30 | 12 Participants |
| ATX-101 1000 mg | Percentage of Subject Who Remain Opioid Free. | Day 5 - Day 30 | 13 Participants |
| ATX-101 1000 mg | Percentage of Subject Who Remain Opioid Free. | Day 8 - Day 30 | 14 Participants |
| ATX-101 1000 mg | Percentage of Subject Who Remain Opioid Free. | Day 15 - Day 30 | 17 Participants |
| ATX-101 1000 mg | Percentage of Subject Who Remain Opioid Free. | Day 22 - Day 30 | 24 Participants |
| ATX-101 1500 mg | Percentage of Subject Who Remain Opioid Free. | Day 22 - Day 30 | 27 Participants |
| ATX-101 1500 mg | Percentage of Subject Who Remain Opioid Free. | Day 8 - Day 30 | 17 Participants |
| ATX-101 1500 mg | Percentage of Subject Who Remain Opioid Free. | Surgical Closure - Day 30 | 6 Participants |
| ATX-101 1500 mg | Percentage of Subject Who Remain Opioid Free. | Day 5 - Day 30 | 15 Participants |
| ATX-101 1500 mg | Percentage of Subject Who Remain Opioid Free. | Day 4 - Day 30 | 13 Participants |
| ATX-101 1500 mg | Percentage of Subject Who Remain Opioid Free. | Day 15 - Day 30 | 22 Participants |
| Bupivacaine Hydrochloride | Percentage of Subject Who Remain Opioid Free. | Day 4 - Day 30 | 6 Participants |
| Bupivacaine Hydrochloride | Percentage of Subject Who Remain Opioid Free. | Day 5 - Day 30 | 6 Participants |
| Bupivacaine Hydrochloride | Percentage of Subject Who Remain Opioid Free. | Day 8 - Day 30 | 10 Participants |
| Bupivacaine Hydrochloride | Percentage of Subject Who Remain Opioid Free. | Day 22 - Day 30 | 23 Participants |
| Bupivacaine Hydrochloride | Percentage of Subject Who Remain Opioid Free. | Day 15 - Day 30 | 16 Participants |
| Bupivacaine Hydrochloride | Percentage of Subject Who Remain Opioid Free. | Surgical Closure - Day 30 | 1 Participants |
| Saline Placebo | Percentage of Subject Who Remain Opioid Free. | Day 15 - Day 30 | 1 Participants |
| Saline Placebo | Percentage of Subject Who Remain Opioid Free. | Day 22 - Day 30 | 1 Participants |
| Saline Placebo | Percentage of Subject Who Remain Opioid Free. | Day 4 - Day 30 | 0 Participants |
| Saline Placebo | Percentage of Subject Who Remain Opioid Free. | Day 8 - Day 30 | 1 Participants |
| Saline Placebo | Percentage of Subject Who Remain Opioid Free. | Surgical Closure - Day 30 | 0 Participants |
| Saline Placebo | Percentage of Subject Who Remain Opioid Free. | Day 5 - Day 30 | 0 Participants |
Secondary
Time to First Rescue Opioid Medication.
Time to first postsurgical use of rescue opioid medication (days).
Time frame: Surgical Closure to Day 30
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATX-101 1000 mg | Time to First Rescue Opioid Medication. | 0.478 Days | Standard Deviation 0.9862 |
| ATX-101 1500 mg | Time to First Rescue Opioid Medication. | 0.257 Days | Standard Deviation 0.2571 |
| Bupivacaine Hydrochloride | Time to First Rescue Opioid Medication. | 0.491 Days | Standard Deviation 0.6925 |
| Saline Placebo | Time to First Rescue Opioid Medication. | 0.223 Days | Standard Deviation 0.082 |
Secondary
Total Post-surgical Use of Rescue Opioid Medications.
Total post-surgical use of rescue opioid medications (days).
Time frame: Surgical Closure to Day 30, Opioid consumption is summarized descriptively every 24-hour period through Day 30
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 26 - Day 27 | 9.844 IV Morphine Milligram Equivalent (MME) | Standard Deviation 6.1397 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 14 - Day 15 | 20.200 IV Morphine Milligram Equivalent (MME) | Standard Deviation 17.2293 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 13 - Day 14 | 13.571 IV Morphine Milligram Equivalent (MME) | Standard Deviation 7.1195 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 8 - Day 9 | 19.147 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.3089 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 25 - Day 26 | 18.750 IV Morphine Milligram Equivalent (MME) | Standard Deviation 14.2705 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 12 - Day 13 | 16.071 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.7289 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 11 - Day 12 | 16.417 IV Morphine Milligram Equivalent (MME) | Standard Deviation 12.7201 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 9 - Day 10 | 20.176 IV Morphine Milligram Equivalent (MME) | Standard Deviation 13.4768 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Hour 48 (Day 2) - Hour 72 (Day 3) | 30.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 25.1244 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 10 - Day 11 | 20.214 IV Morphine Milligram Equivalent (MME) | Standard Deviation 12.4216 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 28 - Day 29 | 17.917 IV Morphine Milligram Equivalent (MME) | Standard Deviation 19.1974 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 24 - Day 25 | 13.906 IV Morphine Milligram Equivalent (MME) | Standard Deviation 14.7515 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 23 - Day 24 | 16.750 IV Morphine Milligram Equivalent (MME) | Standard Deviation 14.1323 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Hour 72 (Day 3) - Day 4 | 24.044 IV Morphine Milligram Equivalent (MME) | Standard Deviation 22.3062 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 29 - Day 30 | 47.500 IV Morphine Milligram Equivalent (MME) | — |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 22 - Day 23 | 19.861 IV Morphine Milligram Equivalent (MME) | Standard Deviation 17.0069 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 21 - Day 22 | 17.273 IV Morphine Milligram Equivalent (MME) | Standard Deviation 14.3267 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 4 - Day 5 | 26.733 IV Morphine Milligram Equivalent (MME) | Standard Deviation 26.0054 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 27 - Day 28 | 18.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 20.661 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 20 - Day 21 | 17.778 IV Morphine Milligram Equivalent (MME) | Standard Deviation 15.1783 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 19 - Day 20 | 17.550 IV Morphine Milligram Equivalent (MME) | Standard Deviation 14.2993 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 5 - Day 6 | 25.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 21.5058 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Hour 24 (Day 1) - Hour 48 (Day 2) | 44.628 IV Morphine Milligram Equivalent (MME) | Standard Deviation 40.0835 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 18 - Day 19 | 17.981 IV Morphine Milligram Equivalent (MME) | Standard Deviation 20.5113 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 17 - Day 18 | 14.271 IV Morphine Milligram Equivalent (MME) | Standard Deviation 8.7331 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 6 - Day 7 | 27.206 IV Morphine Milligram Equivalent (MME) | Standard Deviation 21.8818 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Surgical Closure - Hour 24 (Day 1) | 63.153 IV Morphine Milligram Equivalent (MME) | Standard Deviation 62.6833 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 16 - Day 17 | 14.821 IV Morphine Milligram Equivalent (MME) | Standard Deviation 7.8117 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 15 - Day 16 | 17.045 IV Morphine Milligram Equivalent (MME) | Standard Deviation 11.6092 |
| ATX-101 1000 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 7 - Day 8 | 19.147 IV Morphine Milligram Equivalent (MME) | Standard Deviation 13.7509 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Hour 72 (Day 3) - Day 4 | 23.783 IV Morphine Milligram Equivalent (MME) | Standard Deviation 19.7504 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Surgical Closure - Hour 24 (Day 1) | 58.399 IV Morphine Milligram Equivalent (MME) | Standard Deviation 47.1712 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Hour 24 (Day 1) - Hour 48 (Day 2) | 33.566 IV Morphine Milligram Equivalent (MME) | Standard Deviation 29.9608 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Hour 48 (Day 2) - Hour 72 (Day 3) | 25.795 IV Morphine Milligram Equivalent (MME) | Standard Deviation 18.9251 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 4 - Day 5 | 22.214 IV Morphine Milligram Equivalent (MME) | Standard Deviation 18.1274 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 5 - Day 6 | 24.063 IV Morphine Milligram Equivalent (MME) | Standard Deviation 22.5092 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 6 - Day 7 | 18.923 IV Morphine Milligram Equivalent (MME) | Standard Deviation 13.2725 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 7 - Day 8 | 16.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 9.7033 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 8 - Day 9 | 21.042 IV Morphine Milligram Equivalent (MME) | Standard Deviation 17.014 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 9 - Day 10 | 15.045 IV Morphine Milligram Equivalent (MME) | Standard Deviation 8.326 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 10 - Day 11 | 17.591 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.9654 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 11 - Day 12 | 14.208 IV Morphine Milligram Equivalent (MME) | Standard Deviation 11.3367 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 12 - Day 13 | 15.900 IV Morphine Milligram Equivalent (MME) | Standard Deviation 9.1767 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 13 - Day 14 | 14.591 IV Morphine Milligram Equivalent (MME) | Standard Deviation 7.5459 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 14 - Day 15 | 13.850 IV Morphine Milligram Equivalent (MME) | Standard Deviation 9.6149 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 15 - Day 16 | 17.571 IV Morphine Milligram Equivalent (MME) | Standard Deviation 7.7051 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 16 - Day 17 | 11.167 IV Morphine Milligram Equivalent (MME) | Standard Deviation 4.1307 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 17 - Day 18 | 12.700 IV Morphine Milligram Equivalent (MME) | Standard Deviation 5.7359 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 18 - Day 19 | 12.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 6.1237 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 19 - Day 20 | 7.875 IV Morphine Milligram Equivalent (MME) | Standard Deviation 0.75 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 20 - Day 21 | 13.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 9.5481 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 21 - Day 22 | 11.083 IV Morphine Milligram Equivalent (MME) | Standard Deviation 5.5083 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 22 - Day 23 | 9.750 IV Morphine Milligram Equivalent (MME) | Standard Deviation 3.5707 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 23 - Day 24 | 11.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 4.1683 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 24 - Day 25 | 13.400 IV Morphine Milligram Equivalent (MME) | Standard Deviation 11.0872 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 25 - Day 26 | 12.357 IV Morphine Milligram Equivalent (MME) | Standard Deviation 9.0725 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 26 - Day 27 | 9.857 IV Morphine Milligram Equivalent (MME) | Standard Deviation 3.8699 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 27 - Day 28 | 12.700 IV Morphine Milligram Equivalent (MME) | Standard Deviation 6.9964 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 28 - Day 29 | 11.700 IV Morphine Milligram Equivalent (MME) | Standard Deviation 5.9224 |
| ATX-101 1500 mg | Total Post-surgical Use of Rescue Opioid Medications. | Day 29 - Day 30 | 16.000 IV Morphine Milligram Equivalent (MME) | — |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 18 - Day 19 | 11.411 IV Morphine Milligram Equivalent (MME) | Standard Deviation 9.1744 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 22 - Day 23 | 13.750 IV Morphine Milligram Equivalent (MME) | Standard Deviation 5.6458 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 16 - Day 17 | 18.682 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.6941 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 25 - Day 26 | 13.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 3.3541 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 27 - Day 28 | 10.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 4.3301 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 23 - Day 24 | 11.250 IV Morphine Milligram Equivalent (MME) | Standard Deviation 4.1079 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 26 - Day 27 | 11.250 IV Morphine Milligram Equivalent (MME) | Standard Deviation 7.5 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Hour 48 (Day 2) - Hour 72 (Day 3) | 32.550 IV Morphine Milligram Equivalent (MME) | Standard Deviation 21.3338 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 19 - Day 20 | 14.722 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.1122 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 9 - Day 10 | 20.192 IV Morphine Milligram Equivalent (MME) | Standard Deviation 13.8241 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Surgical Closure - Hour 24 (Day 1) | 43.283 IV Morphine Milligram Equivalent (MME) | Standard Deviation 29.0513 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 10 - Day 11 | 21.100 IV Morphine Milligram Equivalent (MME) | Standard Deviation 13.8824 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 6 - Day 7 | 26.225 IV Morphine Milligram Equivalent (MME) | Standard Deviation 21.1209 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 4 - Day 5 | 23.853 IV Morphine Milligram Equivalent (MME) | Standard Deviation 20.0357 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 24 - Day 25 | 13.750 IV Morphine Milligram Equivalent (MME) | Standard Deviation 3.0619 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 11 - Day 12 | 15.875 IV Morphine Milligram Equivalent (MME) | Standard Deviation 8.077 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Hour 24 (Day 1) - Hour 48 (Day 2) | 36.804 IV Morphine Milligram Equivalent (MME) | Standard Deviation 30.9289 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 8 - Day 9 | 19.833 IV Morphine Milligram Equivalent (MME) | Standard Deviation 13.7369 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 20 - Day 21 | 12.563 IV Morphine Milligram Equivalent (MME) | Standard Deviation 5.2809 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 12 - Day 13 | 21.567 IV Morphine Milligram Equivalent (MME) | Standard Deviation 14.9354 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 17 - Day 18 | 10.232 IV Morphine Milligram Equivalent (MME) | Standard Deviation 8.8154 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 15 - Day 16 | 12.321 IV Morphine Milligram Equivalent (MME) | Standard Deviation 8.5605 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 5 - Day 6 | 25.067 IV Morphine Milligram Equivalent (MME) | Standard Deviation 25.0933 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 13 - Day 14 | 19.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 12.8504 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 21 - Day 22 | 10.972 IV Morphine Milligram Equivalent (MME) | Standard Deviation 4.9124 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 7 - Day 8 | 28.219 IV Morphine Milligram Equivalent (MME) | Standard Deviation 20.8734 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 29 - Day 30 | 7.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 0 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 14 - Day 15 | 14.091 IV Morphine Milligram Equivalent (MME) | Standard Deviation 6.5453 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Day 28 - Day 29 | 6.563 IV Morphine Milligram Equivalent (MME) | Standard Deviation 1.875 |
| Bupivacaine Hydrochloride | Total Post-surgical Use of Rescue Opioid Medications. | Hour 72 (Day 3) - Day 4 | 25.369 IV Morphine Milligram Equivalent (MME) | Standard Deviation 16.9465 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 12 - Day 13 | 12.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 4.3301 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 6 - Day 7 | 27.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 15.6125 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 15 - Day 16 | 15.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.6066 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 25 - Day 26 | 7.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 0 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 16 - Day 17 | 15.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.6066 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 5 - Day 6 | 40.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 22.9129 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 17 - Day 18 | 15.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.6066 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 18 - Day 19 | 7.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 0 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 4 - Day 5 | 37.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 19.8431 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 19 - Day 20 | 11.250 IV Morphine Milligram Equivalent (MME) | Standard Deviation 5.3033 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 26 - Day 27 | 23.750 IV Morphine Milligram Equivalent (MME) | Standard Deviation 22.981 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 20 - Day 21 | 7.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 0 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Hour 72 (Day 3) - Day 4 | 35.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 22.9129 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Surgical Closure - Hour 24 (Day 1) | 119.800 IV Morphine Milligram Equivalent (MME) | Standard Deviation 58.1316 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 21 - Day 22 | 7.500 IV Morphine Milligram Equivalent (MME) | Standard Deviation 0 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 28 - Day 29 | 20.000 IV Morphine Milligram Equivalent (MME) | — |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 22 - Day 23 | 18.333 IV Morphine Milligram Equivalent (MME) | Standard Deviation 18.7639 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Hour 48 (Day 2) - Hour 72 (Day 3) | 40.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 8.6603 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 23 - Day 24 | 31.667 IV Morphine Milligram Equivalent (MME) | Standard Deviation 41.8579 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 9 - Day 10 | 20.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 11.4564 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 10 - Day 11 | 12.750 IV Morphine Milligram Equivalent (MME) | Standard Deviation 3.182 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 8 - Day 9 | 25.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 17.3205 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 11 - Day 12 | 15.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 7.5 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 24 - Day 25 | 18.333 IV Morphine Milligram Equivalent (MME) | Standard Deviation 18.7639 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 14 - Day 15 | 15.000 IV Morphine Milligram Equivalent (MME) | Standard Deviation 10.6066 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 7 - Day 8 | 18.750 IV Morphine Milligram Equivalent (MME) | Standard Deviation 9.9216 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Hour 24 (Day 1) - Hour 48 (Day 2) | 107.250 IV Morphine Milligram Equivalent (MME) | Standard Deviation 50.5486 |
| Saline Placebo | Total Post-surgical Use of Rescue Opioid Medications. | Day 13 - Day 14 | 30.000 IV Morphine Milligram Equivalent (MME) | — |