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The goal of this double-blinded randomized controlled trial is to compare whether the addition of Dronabinol compared to a placebo will affect opioid intake in patients undergoing a total knee arthroplasty. The main question it aims to answer are:
Participants will:
Researchers will compare two groups: 1) intervention group and 2) control group to see if dronabinol affects postoperative opioid consumption 24-48 hours following their total knee arthroplasty surgery.
The objective of this study is to examine the possible therapeutic advantages of administering perioperative dronabinol to individuals who are undergoing unilateral total knee arthroplasty (TKA). With the utilization of contemporary regional anesthetic procedures and peripheral nerve blocks, pain management is typically effective in the immediate aftermath of total knee arthroplasty (TKA) within the first day after surgery. Rebound pain is shown to occur on the second day following postoperative discharge (POD2), once the analgesic blocks administered during the procedure have ceased to be effective. Previous studies have suggested that dronabinol, a synthetic form of THC, may have potential analgesic properties. Our goal is to find out if giving dronabinol before surgery could lower the number of opioids that people need on postoperative day 2 (POD2) in people who are having total knee arthroplasty (TKA). This research could provide valuable insights into alternative pain management strategies for TKA patients, potentially minimizing opioid-related side effects and improving overall patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol | Experimental | 57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. |
|
| Placebo | Placebo Comparator | 57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol 5mg Cap | Drug | Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opioid Consumption 24-48 Hours Post-operatively | The primary outcome of the study will be cumulative patient opioid consumption 24-48 hours post operatively, defined by total morphine equivalents (MEs). This outcome will be measured starting at recovery room entry and conclude at 48 hours after anesthesia stop time. | 24-48 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Discharge From Physical Therapy | Time to reach discharge physical therapy goals, as defined by the number of hours required to meet the following criteria: stable vital signs during Physical therapy (PT), safe independent transfer from bed to standing as well as transfer in and out of seated position, ability to walk 40 feet only with aid of crutch or walker. This outcome will be measured prior to patient discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kethy Jules-Elysee, M.D. | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41838938 | Derived | Thor P, Perlstein M, Illescas A, Lauzadis J, Sheetz M, Tailor M, Puglisi A, Popovic M, Oxendine JA, Lin Y, Kirksey MA, YaDeau JT, Kumar K, Baaklini LR, Liu J, Cheng S, Mayman DJ, Jerabek SA, Westrich GH, Cushner FD, Sculco PK, Sculco TP, Ast MP, Gonzalez Della Valle A, Sideris A, Jules-Elysee KM. Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty: A Double-blinded Randomized Controlled Trial. Anesthesiology. 2026 May 1;144(5):1239-1242. doi: 10.1097/ALN.0000000000005945. Epub 2026 Mar 16. No abstract available. |
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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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Subject enrollment began on 03/09/2021 and ended on 10/04/2023. The last subject follow-up was completed on 04/01/2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dronabinol | 57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. |
| FG001 | Placebo | 57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dronabinol | 57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. |
| BG001 | Placebo |
| 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 | Cumulative Opioid Consumption 24-48 Hours Post-operatively | The primary outcome of the study will be cumulative patient opioid consumption 24-48 hours post operatively, defined by total morphine equivalents (MEs). This outcome will be measured starting at recovery room entry and conclude at 48 hours after anesthesia stop time. | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | 24-48 hours post-operatively |
|
Data were collected up to 6 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 | Dronabinol | 57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maya Tailor | Hospital for Special Surgery | 646-714-6828 | tailorm@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2023 | Mar 3, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Throughout cannabinoid research, there has been concern about potential unblinding due to the side effect profile of this class of medication. Prior meta-analyses have advocated for the use of active placebo, with concern that unblinding may misrepresent the effects of clinical trials. However, due to evidence of histamine receptor involvement in pain transmission, as well as overlap in antihistamine antiemetic use and common cannabinoid side effect profiles, we have chosen to use non-active placebo. Our hope is to elicit maximum benefit of cannabinoid dosing perioperatively without confounding variables. With use of non-active placebo, we will perform a comprehensive blinding analysis following the study period to ensure adequate blinding.
|
| Placebo oral tablet | Other | Non-active placebo |
|
|
| Post operative day 0 (beginning in the PACU)-Discharge |
| Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS) | Patient pain with ambulation on postoperative day (POD) 1, 2, 7, 90 and 180, defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable). | Post operative day 1, 2, 7, 90 and 180 |
| Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS) | Patient pain at rest upon PACU entry and in the morning of postoperative day (POD)1, POD2, POD7, POD90 and POD180 defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable). | Post operative day 0 (beginning in the PACU), POD 1, 2, 7, 90 and 180 |
| Pain With Physical Therapy | Patient pain during morning physical therapy on postoperative day (POD)1 and 2, defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable). | Postoperative Day 1 and Postoperative Day 2 |
| Length of Hospital Stay (Hours) | Hospital length of stay from procedure start time to time of discharge | Post operative day 0 (beginning in the PACU)-Discharge |
| the Number of Desaturation Events | Postoperative desaturation events are defined as the number of times oxygen saturation dropped below 88% for at least 20 seconds or more. The number of such events will be counted per subject during the monitoring period, beginning in the immediate postoperative period on postoperative day (POD)0 (in the PACU) and will continue until the end post operative day 2/patient discharge, whichever occurs first. Oxygen desaturation is defined when measured SpO2 is less than 88%. Measurements will only be recorded if the desaturation event happens for 20 seconds or longer. | Post operative day 0 (beginning in the PACU)-48 hours post operative discharge |
| PainOUT Scale Questions | PainOut assesses post-surgical pain by collecting data on pain intensity, interference with daily activities, and other related factors. Questionnaire uses multiple scales from 0 (none/not at all/did not interfere/extremely dissatisfied) to 10 (extreme/severe/worst pain imaginable/completely interfered/extremely satisfied). Pain severity/Interference/Symptom questions are scored from 0-10, with higher scores indicating worse outcomes. With a scale of 0-10, higher scores indicate better outcomes for the following questions: decision participation question and satisfaction question. The following questions used a scale of 1-11, where 1=0% and 11=100%: Pain relief (a higher percentage indicates better outcome) Time with severe pain (a higher percentage indicates worse outcome) | 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge |
| PainOut Count Questions | The following questions used a scale of Yes/No, reporting number of patients with Yes
| 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge |
| DN4 Score | DN4 questionnaire to assess neuropathic pain on postoperative day (POD)1, 2, 7, 90 and 180. The DN4 questionnaire is a series of Yes or No questions that revolves around the characteristics that may suggest the presence or development of neuropathic conditions/pain (burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching, hypoesthesia to touch, hypoesthesia to pinprick, pain increased by brushing). 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. | 24 hours post operative discharge, 48 hours post operative discharge, 7days post operative discharge, 3 months post operative discharge, 6 months post operative discharge |
| Opioid-Related Symptom Distress (ORSDS) Scale | The Opioid-Related Symptom Distress Scale (ORSDS) is a scale that assesses three dimensions of symptom distress (frequency, severity, and bothersomeness) for 12 symptoms. The symptom-specific ORSDS is calculated by taking the average of the three symptom distress dimensions. The composite score will be reported for postoperative day (POD)1 and POD2. If a patient denies experiencing a particular symptom, their response will be coded as 0. If they do: Frequency will be assessed using a 4 point scale:
with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale:
with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale:
with 1 being the lowest and 5 being the highest. | 24 hours post operative discharge, 48 hours post operative discharge |
| Non-opioid Analgesic Consumption | Patient consumption of non-opioid analgesics in the post-anesthesia care unit (PACU) and on postoperative day (POD)1, POD2, POD7. This was measured for acetaminophen, ibuprofen, ketorolac, meloxicam, naproxen, and gabapentin as yes/no. Number of participants who report "yes" for each non-opioid analgesic is reported. | PACU, POD1, POD2, POD7 |
| Sleep Disturbance: Total Sleep Time | Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Measured during the first 24 hours postoperatively. | Post operative day 0 (beginning in the PACU)- 24 hours post operative |
| Sleep Disturbance: Wake After Sleep Onset | Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Wake After Sleep Onset is the duration of time a patient was awake after falling asleep and before getting out of bed. Measured during the first 24 hours postoperatively. | Post operative day 0 (beginning in the PACU)- 24 hours post operative |
| Sleep Disturbance: Sleep Efficiency | Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Sleep Efficiency is the ratio between total sleep time and the total time in bed. Measured during the first 24 hours postoperatively. Sleep Efficiency ratio is expressed as a percentage, where higher values represent better outcomes. | Post operative day 0 (beginning in the PACU)- 24 hours post operative |
| Sleep Disturbance: Number of Awakenings | Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Measured as number of awakenings during the first 24 hours postoperatively. | Post operative day 0 (beginning in the PACU)- 24 hours post operative |
| Cognitive Assessment | Measured as yes/no for a series of 13 questions asking patients if they have experienced any: change of mood, difficulty with memory, slurring of speech, blurred vision, hallucinations, increased awareness of surroundings, palpitations, headache, dizziness, drowsiness, dry mouth, involuntary muscle twitching, or tremors. Number of participants who report "yes" for each symptom is reported. Measured in the post-anesthesia care unit (PACU), between PACU exist and midnight (Post-op), postoperative day (POD)1, POD2 | PACU, Post-Op, POD1, POD2 |
| Opioid Consumption in the Post-anesthesia Care Unit and Postoperative Day 1 | Opioid consumption measured in morphine milligram equivalents in the post-anesthesia care unit and postoperative day 1 (analyzed as 0-24 hours after surgery) | post-anesthesia care unit and postoperative day 1 |
| Opioid Consumption at Postoperative Day 90 | Number of participants reporting opioid use at postoperative day 90. | Postoperative Day 90 |
57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. |
| 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 |
|
| American Society of Anesthesiologists (ASA) Class | ASA Class of 1 represents a healthy patient, ASA 2 represents a patient with systemic disease that is mild, ASA 3 represents a patient with systemic disease that is severe but not life-threatening. | Number | participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| OG001 | Placebo | 57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. Placebo oral tablet: Non-active placebo |
|
|
|
| Secondary | Time to Reach Discharge From Physical Therapy | Time to reach discharge physical therapy goals, as defined by the number of hours required to meet the following criteria: stable vital signs during Physical therapy (PT), safe independent transfer from bed to standing as well as transfer in and out of seated position, ability to walk 40 feet only with aid of crutch or walker. This outcome will be measured prior to patient discharge. | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | hours | Post operative day 0 (beginning in the PACU)-Discharge |
|
|
|
|
| Secondary | Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS) | Patient pain with ambulation on postoperative day (POD) 1, 2, 7, 90 and 180, defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable). | Participants were lost to follow up/withdrawn. | Posted | Mean | Standard Error | units on a scale | Post operative day 1, 2, 7, 90 and 180 |
|
|
|
|
| Secondary | Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS) | Patient pain at rest upon PACU entry and in the morning of postoperative day (POD)1, POD2, POD7, POD90 and POD180 defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable). | Participants were lost to follow up/withdrawn. | Posted | Mean | Standard Error | units on a scale | Post operative day 0 (beginning in the PACU), POD 1, 2, 7, 90 and 180 |
|
|
|
|
| Secondary | Pain With Physical Therapy | Patient pain during morning physical therapy on postoperative day (POD)1 and 2, defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable). | Participants were lost to follow up/withdrawn. | Posted | Mean | Standard Error | units on a scale | Postoperative Day 1 and Postoperative Day 2 |
|
|
|
|
| Secondary | Length of Hospital Stay (Hours) | Hospital length of stay from procedure start time to time of discharge | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | hours | Post operative day 0 (beginning in the PACU)-Discharge |
|
|
|
|
| Secondary | the Number of Desaturation Events | Postoperative desaturation events are defined as the number of times oxygen saturation dropped below 88% for at least 20 seconds or more. The number of such events will be counted per subject during the monitoring period, beginning in the immediate postoperative period on postoperative day (POD)0 (in the PACU) and will continue until the end post operative day 2/patient discharge, whichever occurs first. Oxygen desaturation is defined when measured SpO2 is less than 88%. Measurements will only be recorded if the desaturation event happens for 20 seconds or longer. | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | number of events | Post operative day 0 (beginning in the PACU)-48 hours post operative discharge |
|
|
|
|
| Secondary | PainOUT Scale Questions | PainOut assesses post-surgical pain by collecting data on pain intensity, interference with daily activities, and other related factors. Questionnaire uses multiple scales from 0 (none/not at all/did not interfere/extremely dissatisfied) to 10 (extreme/severe/worst pain imaginable/completely interfered/extremely satisfied). Pain severity/Interference/Symptom questions are scored from 0-10, with higher scores indicating worse outcomes. With a scale of 0-10, higher scores indicate better outcomes for the following questions: decision participation question and satisfaction question. The following questions used a scale of 1-11, where 1=0% and 11=100%: Pain relief (a higher percentage indicates better outcome) Time with severe pain (a higher percentage indicates worse outcome) | Participants were lost to follow up/withdrawn. | Posted | Mean | Standard Error | score on a scale | 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge |
|
|
|
|
| Secondary | PainOut Count Questions | The following questions used a scale of Yes/No, reporting number of patients with Yes
| Participants were lost to follow up/withdrawn. | Posted | Count of Participants | Participants | 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge |
|
|
|
| Secondary | DN4 Score | DN4 questionnaire to assess neuropathic pain on postoperative day (POD)1, 2, 7, 90 and 180. The DN4 questionnaire is a series of Yes or No questions that revolves around the characteristics that may suggest the presence or development of neuropathic conditions/pain (burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching, hypoesthesia to touch, hypoesthesia to pinprick, pain increased by brushing). 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. | Participants were lost to follow up/withdrawn. | Posted | Mean | Standard Error | score on a scale | 24 hours post operative discharge, 48 hours post operative discharge, 7days post operative discharge, 3 months post operative discharge, 6 months post operative discharge |
|
|
|
|
| Secondary | Opioid-Related Symptom Distress (ORSDS) Scale | The Opioid-Related Symptom Distress Scale (ORSDS) is a scale that assesses three dimensions of symptom distress (frequency, severity, and bothersomeness) for 12 symptoms. The symptom-specific ORSDS is calculated by taking the average of the three symptom distress dimensions. The composite score will be reported for postoperative day (POD)1 and POD2. If a patient denies experiencing a particular symptom, their response will be coded as 0. If they do: Frequency will be assessed using a 4 point scale:
with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale:
with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale:
with 1 being the lowest and 5 being the highest. | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours post operative discharge, 48 hours post operative discharge |
|
|
|
|
| Secondary | Non-opioid Analgesic Consumption | Patient consumption of non-opioid analgesics in the post-anesthesia care unit (PACU) and on postoperative day (POD)1, POD2, POD7. This was measured for acetaminophen, ibuprofen, ketorolac, meloxicam, naproxen, and gabapentin as yes/no. Number of participants who report "yes" for each non-opioid analgesic is reported. | Participants were lost to follow up/withdrawn. | Posted | Count of Participants | Participants | PACU, POD1, POD2, POD7 |
|
|
|
| Secondary | Sleep Disturbance: Total Sleep Time | Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Measured during the first 24 hours postoperatively. | Participants were lost to follow up/withdrawn | Posted | Median | Inter-Quartile Range | minutes | Post operative day 0 (beginning in the PACU)- 24 hours post operative |
|
|
|
|
| Secondary | Sleep Disturbance: Wake After Sleep Onset | Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Wake After Sleep Onset is the duration of time a patient was awake after falling asleep and before getting out of bed. Measured during the first 24 hours postoperatively. | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | minutes | Post operative day 0 (beginning in the PACU)- 24 hours post operative |
|
|
|
|
| Secondary | Sleep Disturbance: Sleep Efficiency | Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Sleep Efficiency is the ratio between total sleep time and the total time in bed. Measured during the first 24 hours postoperatively. Sleep Efficiency ratio is expressed as a percentage, where higher values represent better outcomes. | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | percentage of sleep time | Post operative day 0 (beginning in the PACU)- 24 hours post operative |
|
|
|
|
| Secondary | Sleep Disturbance: Number of Awakenings | Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Measured as number of awakenings during the first 24 hours postoperatively. | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | awakening events | Post operative day 0 (beginning in the PACU)- 24 hours post operative |
|
|
|
|
| Secondary | Cognitive Assessment | Measured as yes/no for a series of 13 questions asking patients if they have experienced any: change of mood, difficulty with memory, slurring of speech, blurred vision, hallucinations, increased awareness of surroundings, palpitations, headache, dizziness, drowsiness, dry mouth, involuntary muscle twitching, or tremors. Number of participants who report "yes" for each symptom is reported. Measured in the post-anesthesia care unit (PACU), between PACU exist and midnight (Post-op), postoperative day (POD)1, POD2 | Participants were lost to follow up/withdrawn. | Posted | Count of Participants | Participants | PACU, Post-Op, POD1, POD2 |
|
|
|
| Secondary | Opioid Consumption in the Post-anesthesia Care Unit and Postoperative Day 1 | Opioid consumption measured in morphine milligram equivalents in the post-anesthesia care unit and postoperative day 1 (analyzed as 0-24 hours after surgery) | Participants were lost to follow up/withdrawn. | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | post-anesthesia care unit and postoperative day 1 |
|
|
|
|
| Secondary | Opioid Consumption at Postoperative Day 90 | Number of participants reporting opioid use at postoperative day 90. | Participants were lost to follow up/withdrawn. | Posted | Count of Participants | Participants | Postoperative Day 90 |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Placebo | 57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2. | 0 | 56 | 0 | 56 | 0 | 56 |
Not provided
Not provided
Not provided
| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| POD2 |
|
|
| POD7 |
|
|
| POD90 |
|
|
| POD180 |
|
|
| 0.182 |
| Superiority |
| POD7 | Generalized Estimating Equation | 0.371 | Superiority |
| POD90 | Generalized Estimating Equation | 0.449 | Superiority |
| POD180 | Generalized Estimating Equation | 0.997 | Superiority |
| POD1 |
|
|
| POD2 |
|
|
| POD7 |
|
|
| POD90 |
|
|
| POD180 |
|
|
| 0.722 |
| Superiority |
| POD2 | Generalized Estimating Equation | 0.943 | Superiority |
| POD7 | Generalized Estimating Equation | 0.914 | Superiority |
| POD90 | Generalized Estimating Equation | 0.535 | Superiority |
| POD180 | Generalized Estimating Equation | 0.907 | Superiority |
| POD2 |
|
|
| 0.667 |
| Superiority |
| Worst Pain: POD2 |
|
|
| Worst Pain: POD7 |
|
|
| Worst Pain: POD90 |
|
|
| Worst Pain: POD180 |
|
|
| Least Pain: POD1 |
|
|
| Least Pain: POD2 |
|
|
| Least Pain: POD7 |
|
|
| Least Pain: POD90 |
|
|
| Least Pain: POD180 |
|
|
| Interference with doing activities in bed, such as turning, sitting up, and changing position POD1 |
|
|
| Interference with doing activities in bed, such as turning, sitting up, and changing position POD2 |
|
|
| Interference with doing activities in bed, such as turning, sitting up, and changing position POD7 |
|
|
| Interference with doing activities in bed, such as turning, sitting up, and changing position POD90 |
|
|
| Interference with doing activities in bed: turning, sitting up, and changing position POD180 |
|
|
| Interference with breathing deeply or coughing POD1 |
|
|
| Interference with breathing deeply or coughing POD2 |
|
|
| Interference with breathing deeply or coughing POD7 |
|
|
| Interference with breathing deeply or coughing POD90 |
|
|
| Interference with breathing deeply or coughing POD180 |
|
|
| Interference with sleeping POD1 |
|
|
| Interference with sleeping POD2 |
|
|
| Interference with sleeping POD7 |
|
|
| Interference with sleeping POD90 |
|
|
| Interference with sleeping POD180 |
|
|
| Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD1 |
|
|
| Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD2 |
|
|
| Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD7 |
|
|
| Interference with doing activities out of bed:walking, sitting in a chair, standing at a sink POD90 |
|
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| Interference with doing activities out of bed:walking, sitting in a chair,standing at a sink POD180 |
|
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| Pain causing patients to feel anxious POD1 |
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| Pain causing patients to feel anxious POD2 |
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| Pain causing patients to feel anxious POD7 |
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| Pain causing patients to feel anxious POD90 |
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| Pain causing patients to feel anxious POD180 |
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| Pain causing patients to feel helpless POD1 |
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| Pain causing patients to feel helpless POD2 |
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| Pain causing patients to feel helpless POD7 |
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| Pain causing patients to feel helpless POD90 |
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| Pain causing patients to feel helpless POD180 |
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| Nausea POD1 |
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| Nausea POD2 |
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| Nausea POD7 |
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| Nausea POD90 |
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| Nausea POD180 |
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| Drowsiness POD1 |
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| Drowsiness POD2 |
|
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| Drowsiness POD7 |
|
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| Drowsiness POD90 |
|
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| Drowsiness POD180 |
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|
| Itching POD1 |
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| Itching POD2 |
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| Itching POD7 |
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| Itching POD90 |
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| Itching POD180 |
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|
| Dizziness POD1 |
|
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| Dizziness POD2 |
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| Dizziness POD7 |
|
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| Dizziness POD90 |
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| Dizziness POD180 |
|
|
| Participation in decisions about pain treatment POD1 |
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| Participation in decisions about pain treatment POD2 |
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| Participation in decisions about pain treatment POD7 |
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| Participation in decisions about pain treatment POD90 |
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| Participation in decisions about pain treatment POD180 |
|
|
| Satisfaction with results of pain management treatment POD1 |
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| Satisfaction with results of pain management treatment POD2 |
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| Satisfaction with results of pain management treatment POD7 |
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| Satisfaction with results of pain management treatment POD90 |
|
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| Satisfaction with results of pain management treatment POD180 |
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|
| Pain severity POD1 |
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| Pain severity POD2 |
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| Pain severity POD7 |
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| Pain severity POD90 |
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| Pain severity POD180 |
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| Pain relief POD1 |
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| Pain relief POD2 |
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| Pain relief POD7 |
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| Pain relief POD90 |
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| Pain relief POD180 |
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| Time with severe pain POD1 |
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| Time with severe pain POD2 |
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| Time with severe pain POD7 |
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| Time with severe pain POD90 |
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| Time with severe pain POD180 |
|
|
| 0.819 |
| Superiority |
| Worst Pain: POD7 | Generalized Estimating Equation | 0.497 | Superiority |
| Worst Pain: POD90 | Generalized Estimating Equation | 0.160 | Superiority |
| Worst Pain: POD180 | Generalized Estimating Equation | 0.561 | Superiority |
| Least Pain: POD1 | Generalized Estimating Equation | 0.301 | Superiority |
| Least Pain: POD2 | Generalized Estimating Equation | 0.938 | Superiority |
| Least Pain: POD7 | Generalized Estimating Equation | 0.524 | Superiority |
| Least Pain: POD90 | Generalized Estimating Equation | 0.585 | Superiority |
| Least Pain: POD180 | Generalized Estimating Equation | 0.250 | Superiority |
| Interference with doing activities in bed, such as turning, sitting up, and changing position POD1 | Generalized Estimating Equation | 0.947 | Superiority |
| Interference with doing activities in bed, such as turning, sitting up, and changing position POD2 | Generalized Estimating Equation | 0.958 | Superiority |
| Interference with doing activities in bed, such as turning, sitting up, and changing position POD7 | Generalized Estimating Equation | 0.574 | Superiority |
| Interference with doing activities in bed, such as turning, sitting up, and changing position POD90 | Generalized Estimating Equation | 0.105 | Superiority |
| Interference with doing activities in bed: turning, sitting up, and changing position POD180 | Generalized Estimating Equation | 0.116 | Superiority |
| Interference with breathing deeply or coughing POD1 | Generalized Estimating Equation | 0.084 | Superiority |
| Interference with breathing deeply or coughing POD2 | Generalized Estimating Equation | 0.292 | Superiority |
| Interference with breathing deeply or coughing POD7 | Generalized Estimating Equation | 0.632 | Superiority |
| Interference with breathing deeply or coughing POD90 | Generalized Estimating Equation | 0.213 | Superiority |
| Interference with breathing deeply or coughing POD180 | Generalized Estimating Equation | 0.595 | Superiority |
| Interference with sleeping POD1 | Generalized Estimating Equation | 1 | Superiority |
| Interference with sleeping POD2 | Generalized Estimating Equation | 0.879 | Superiority |
| Interference with sleeping POD7 | Generalized Estimating Equation | 0.871 | Superiority |
| Interference with sleeping POD90 | Generalized Estimating Equation | 0.966 | Superiority |
| Interference with sleeping POD180 | Generalized Estimating Equation | 0.486 | Superiority |
| Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD1 | Generalized Estimating Equation | 0.706 | Superiority |
| Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD2 | Generalized Estimating Equation | 0.517 | Superiority |
| Interference with doing activities out of bed: walking, sitting in a chair, standing at a sink POD7 | Generalized Estimating Equation | 0.452 | Superiority |
| Interference with doing activities out of bed:walking, sitting in a chair, standing at a sink POD90 | Generalized Estimating Equation | 0.043 | Superiority |
| Interference with doing activities out of bed:walking, sitting in a chair,standing at a sink POD180 | Generalized Estimating Equation | 0.988 | Superiority |
| Pain causing patients to feel anxious POD1 | Generalized Estimating Equation | 0.603 | Superiority |
| Pain causing patients to feel anxious POD2 | Generalized Estimating Equation | 0.215 | Superiority |
| Pain causing patients to feel anxious POD7 | Generalized Estimating Equation | 0.883 | Superiority |
| Pain causing patients to feel anxious POD90 | Generalized Estimating Equation | 0.249 | Superiority |
| Pain causing patients to feel anxious POD180 | Generalized Estimating Equation | 0.418 | Superiority |
| Pain causing patients to feel helpless POD1 | Generalized Estimating Equation | 0.93 | Superiority |
| Pain causing patients to feel helpless POD2 | Generalized Estimating Equation | 0.066 | Superiority |
| Pain causing patients to feel helpless POD7 | Generalized Estimating Equation | 0.665 | Superiority |
| Pain causing patients to feel helpless POD90 | Generalized Estimating Equation | 0.706 | Superiority |
| Pain causing patients to feel helpless POD180 | Generalized Estimating Equation | 0.168 | Superiority |
| Nausea POD1 | Generalized Estimating Equation | 0.468 | Superiority |
| Nausea POD2 | Generalized Estimating Equation | 0.705 | Superiority |
| Nausea POD7 | Generalized Estimating Equation | 0.749 | Superiority |
| Nausea POD90 | Generalized Estimating Equation | 0.815 | Superiority |
| Nausea POD180 | Generalized Estimating Equation | 0.152 | Superiority |
| Drowsiness POD1 | Generalized Estimating Equation | 0.791 | Superiority |
| Drowsiness POD2 | Generalized Estimating Equation | 0.727 | Superiority |
| Drowsiness POD7 | Generalized Estimating Equation | 0.504 | Superiority |
| Drowsiness POD90 | Generalized Estimating Equation | 0.683 | Superiority |
| Drowsiness POD180 | Generalized Estimating Equation | 0.242 | Superiority |
| Itching POD1 | Generalized Estimating Equation | 0.134 | Superiority |
| Itching POD2 | Generalized Estimating Equation | 0.571 | Superiority |
| Itching POD7 | Generalized Estimating Equation | 0.807 | Superiority |
| Itching POD90 | Generalized Estimating Equation | 0.13 | Superiority |
| Itching POD180 | Generalized Estimating Equation | 0.237 | Superiority |
| Dizziness POD1 | Generalized Estimating Equation | 0.496 | Superiority |
| Dizziness POD2 | Generalized Estimating Equation | 0.52 | Superiority |
| Dizziness POD7 | Generalized Estimating Equation | 0.557 | Superiority |
| Dizziness POD90 | Generalized Estimating Equation | 0.305 | Superiority |
| Dizziness POD180 | Generalized Estimating Equation | 0.481 | Superiority |
| Participation in decisions about pain treatment POD1 | Generalized Estimating Equation | 0.151 | Superiority |
| Participation in decisions about pain treatment POD2 | Generalized Estimating Equation | 0.683 | Superiority |
| Participation in decisions about pain treatment POD7 | Generalized Estimating Equation | 0.752 | Superiority |
| Participation in decisions about pain treatment POD90 | Generalized Estimating Equation | 0.236 | Superiority |
| Participation in decisions about pain treatment POD180 | Generalized Estimating Equation | 0.992 | Superiority |
| Satisfaction with results of pain management treatment POD1 | Generalized Estimating Equation | 0.259 | Superiority |
| Satisfaction with results of pain management treatment POD2 | Generalized Estimating Equation | 0.613 | Superiority |
| Satisfaction with results of pain management treatment POD7 | Generalized Estimating Equation | 0.716 | Superiority |
| Satisfaction with results of pain management treatment POD90 | Generalized Estimating Equation | 0.840 | Superiority |
| Satisfaction with results of pain management treatment POD180 | Generalized Estimating Equation | 0.342 | Superiority |
| Pain severity POD1 | Generalized Estimating Equation | 0.296 | Superiority |
| Pain severity POD2 | Generalized Estimating Equation | 0.488 | Superiority |
| Pain severity POD7 | Generalized Estimating Equation | 0.790 | Superiority |
| Pain severity POD90 | Generalized Estimating Equation | 0.710 | Superiority |
| Pain severity POD180 | Generalized Estimating Equation | 0.840 | Superiority |
| Pain relief POD1 | Generalized Estimating Equation | 0.6655 | Superiority |
| Pain relief POD2 | Generalized Estimating Equation | 0.8015 | Superiority |
| Pain relief POD7 | Generalized Estimating Equation | 0.1676 | Superiority |
| Pain relief POD90 | Generalized Estimating Equation | 0.0533 | Superiority |
| Pain relief POD180 | Generalized Estimating Equation | 0.5063 | Superiority |
| Time with severe pain POD1 | Generalized Estimating Equation | 0.7492 | Superiority |
| Time with severe pain POD2 | Generalized Estimating Equation | 0.9219 | Superiority |
| Time with severe pain POD7 | Generalized Estimating Equation | 0.397 | Superiority |
| Time with severe pain POD90 | Generalized Estimating Equation | 0.0521 | Superiority |
| Time with severe pain POD180 | Generalized Estimating Equation | 0.162 | Superiority |
| Been out of bed since surgery : POD2 |
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| Been out of bed since surgery : POD7 |
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| Been out of bed since surgery : POD90 |
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| Been out of bed since surgery : POD180 |
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| Would have liked more pain treatment : POD1 |
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| Would have liked more pain treatment : POD2 |
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| Would have liked more pain treatment : POD7 |
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| Would have liked more pain treatment : POD90 |
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| Would have liked more pain treatment : POD180 |
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| Received information about pain treatment : POD1 |
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| Received information about pain treatment : POD2 |
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| Received information about pain treatment : POD7 |
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| Received information about pain treatment : POD90 |
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| Received information about pain treatment : POD180 |
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| Used non-medicine methods to relieve pain : POD1 |
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| Used non-medicine methods to relieve pain : POD2 |
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| Used non-medicine methods to relieve pain : POD7 |
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| Used non-medicine methods to relieve pain : POD90 |
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| Used non-medicine methods to relieve pain : POD180 |
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| Persistent painful condition for 3 months or more : POD1 |
|
|
| Persistent painful condition for 3 months or more : POD2 |
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| Persistent painful condition for 3 months or more : POD7 |
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| Persistent painful condition for 3 months or more : POD90 |
|
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| Persistent painful condition for 3 months or more : POD180 |
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|
| POD2 |
|
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| POD7 |
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|
| POD90 |
|
|
| POD180 |
|
|
| 0.354 |
| Superiority |
| POD7 | Generalized Estimating Equation | 0.002 | Superiority |
| POD90 | Generalized Estimating Equation | 0.213 | Superiority |
| POD180 | Generalized Estimating Equation | 0.569 | Superiority |
| POD2 |
|
|
| 0.09 |
| Superiority |
| Acetaminophen : POD1 |
|
|
| Acetaminophen : POD2 |
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|
| Acetaminophen : POD7 |
|
|
| Ibuprofen : PACU |
|
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| Ibuprofen : POD1 |
|
|
| Ibuprofen : POD2 |
|
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| Ibuprofen : POD7 |
|
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| Ketorolac : PACU |
|
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| Ketorolac : POD1 |
|
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| Ketorolac : POD2 |
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| Ketorolac : POD7 |
|
|
| Meloxicam : PACU |
|
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| Meloxicam : POD1 |
|
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| Meloxicam : POD2 |
|
|
| Meloxicam : POD7 |
|
|
| Naproxen : PACU |
|
|
| Naproxen : POD1 |
|
|
| Naproxen : POD2 |
|
|
| Naproxen : POD7 |
|
|
| Gabapentin : PACU |
|
|
| Gabapentin : POD1 |
|
|
| Gabapentin : POD2 |
|
|
| Gabapentin : POD7 |
|
|
| PACU : Difficulty with Memory |
|
|
| PACU : Slurring of Speech |
|
|
| PACU : Blurred Vision |
|
|
| PACU : Hallucinations |
|
|
| PACU : Increased Awareness of Surroundings |
|
|
| PACU : Palpitations |
|
|
| PACU : Headache |
|
|
| PACU : Dizziness |
|
|
| PACU : Drowsiness |
|
|
| PACU : Dry Mouth |
|
|
| PACU : Involuntary Muscle Twitching |
|
|
| PACU : Tremors |
|
|
| Post-Op : Change of Mood |
|
|
| Post-Op : Difficulty with Memory |
|
|
| Post-Op : Slurring of Speech |
|
|
| Post-Op : Blurred Vision |
|
|
| Post-Op : Hallucinations |
|
|
| Post-Op : Increased Awareness of Surroundings |
|
|
| Post-Op : Palpitations |
|
|
| Post-Op : Headache |
|
|
| Post-Op : Dizziness |
|
|
| Post-Op : Drowsiness |
|
|
| Post-Op : Dry Mouth |
|
|
| Post-Op : Involuntary Muscle Twitching |
|
|
| Post-Op : Tremors |
|
|
| POD1 : Change of Mood |
|
|
| POD1 : Difficulty with Memory |
|
|
| POD1 : Slurring of Speech |
|
|
| POD1 : Blurred Vision |
|
|
| POD1 : Hallucinations |
|
|
| POD1 : Increased Awareness of Surroundings |
|
|
| POD1 : Palpitations |
|
|
| POD1 : Headache |
|
|
| POD1 : Dizziness |
|
|
| POD1 : Drowsiness |
|
|
| POD1 : Dry Mouth |
|
|
| POD1 : Involuntary Muscle Twitching |
|
|
| POD1 : Tremors |
|
|
| POD2 : Change of Mood |
|
|
| POD2 : Difficulty with Memory |
|
|
| POD2 : Slurring of Speech |
|
|
| POD2 : Blurred Vision |
|
|
| POD2 : Hallucinations |
|
|
| POD2 : Increased Awareness of Surroundings |
|
|
| POD2 : Palpitations |
|
|
| POD2 : Headache |
|
|
| POD2 : Dizziness |
|
|
| POD2 : Drowsiness |
|
|
| POD2 : Dry Mouth |
|
|
| POD2 : Involuntary Muscle Twitching |
|
|
| POD2 : Tremors |
|
|