Opioid Use
Conditions
Keywords
3rd molar extraction pain model, Opioid Analgesics, Opioid Diversion, Over the counter analgesics, Acetaminophen, Ibuprofen, Hydrocodone, Opioid Addiction, Pain Management, Satisfaction
Brief summary
The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results. This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.
Interventions
DRUGopioid-containing analgesic
hydrocodone/ acetaminophen combination product
DRUGtwo over-the-counter analgesics
combination of over-the-counter analgesics (ibuprofen/acetaminophen)
Sponsors
Rutgers, The State University of New Jersey
National Institute of Dental and Craniofacial Research (NIDCR)
University of Rochester
University of Maryland, Baltimore
University of Illinois at Chicago
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study was a double-blinded study. The participant, care provider, site directors and site research coordinators were all blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
An individual must meet all of the following criteria to be eligible to participate in the study: * Be able to understand the informed consent. * Provide signed and dated informed consent form * Be able to understand all directions for data gathering instruments in English * Be willing and able to comply with all study procedures and be available for the duration of the study * Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars * Be 18 years or older * Be in good general health as evidenced by medical history * Women must agree to use one of the following methods of contraception while participating in this study: * contraceptive pill * intra-uterine device * condoms * abstinence
Exclusion criteria
Participants who self-report the following history will be excluded from participating: * History of gastrointestinal bleeding and/or peptic ulcer * History of renal disease (excluding kidney stones) * History of hepatic disease * History of bleeding disorder * History of respiratory depression * Any prior respiratory effect of an opioid or other anesthetic drugs that required respiratory support postoperatively * Active or untreated asthma * History of known allegoric reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia * Currently taking any of the following medications: * CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression * CNS depressants. * Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism * History of drug or alcohol abuse * Family history of drug or alcohol abuse in a first-degree relative * Has had no more than one opioid prescription filled within the past 12 months * Currently pregnant or lactating Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes: * Prior participation in this study * Inability or refusal to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Average 3 | End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery) | Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery). |
| Composite Pain 1 | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) | Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery). |
| Composite Pain 2 | End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery) | Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery). |
| Composite Pain 3 | End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery) | Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery). |
| Composite Pain All | End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery) | Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery). |
| Overall Satisfaction | At time of post-operative visit (day 9 +/- 5 days) | Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?" |
| Pain Worst 1 | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) | Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery). |
| Pain Worst 2 | End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery | Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.) |
| Pain Worst 3 | End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery) | Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery). |
| Pain Worst All | End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery) | Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery). |
| Pain Average 1 | End of day of surgery (day 1) and when waking up the next morning (1 night after surgery) | Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery) |
| Pain Average 2 | End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery) | Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.) |
| Pain Average All | End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery) | Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep All | First 7 nights after surgery | Participants were asked to rate the overall quality of their sleep for the first 7 nights after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep All is the average rating provided for all seven nights. |
| Number of Participants Receiving Rescue Medication | At post operative visit (9 days after surgery +/- 5 days) | Participant receiving additional pain medication (oxycodone) as study analgesic is not managing pain sufficiently |
| Pain Interference 1 | End of the day of surgery (day 1) | Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 1 is the average ratings provided at the end of the day of surgery. Lower scores are better. |
| Pain Interference 2 | End of the first full day after surgery (day 2) | Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 2 is the average ratings provided at the end of day after surgery (day 2). Lower scores are better. |
| Pain Interference 3 | End of the second full day after surgery (day 3) | Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 3 is the average ratings provided at the end of 2nd day after surgery (day 3). Lower scores are better. |
| Pain Interference All | First 7 days after surgery | Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference ALL is the average ratings provided at the end of the 1st seven days after surgery (days 1 thru 7). Lower scores are better. |
| Sleep 1 | When first waking up the day after surgery | Participants were asked to rate the overall quality of their sleep the 1st night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the day after surgery. |
| Sleep 2 | When first waking up the 2nd day after surgery | Participants were asked to rate the overall quality of their sleep the 2nd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 2 is the rating provided when first waking up the second day after surgery. |
| Sleep 3 | When first waking up the 3rd day after surgery | Participants were asked to rate the overall quality of their sleep the 3rd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the third day after surgery. |
| Potential for Opioid Tablet Diversion | At post operative visit (9 days after surgery +/- 5 days) | Number of returned opioid analgesic capsules at post operative visit (9 days after surgery +/- 5 days) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCecile A Feldman, DMD
Rutgers, The State University of New Jersey
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Opioid Combination of ibuprofen 400 mg/acetaminophen 500 mg
two over-the-counter analgesics: combination of over-the-counter analgesics (ibuprofen/acetaminophen) | 909 |
| Opioid Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
opioid-containing analgesic: hydrocodone/ acetaminophen combination product | 906 |
| Total | 1,815 |
Baseline characteristics
| Characteristic | Non-Opioid | Total | Opioid |
|---|---|---|---|
| 3rd molars extracted | 2.75 teeth STANDARD_DEVIATION 1.17 | 2.75 teeth STANDARD_DEVIATION 1.19 | 2.75 teeth STANDARD_DEVIATION 1.21 |
| Age, Continuous Age | 25.58 Years STANDARD_DEVIATION 5.97 | 25.69 Years STANDARD_DEVIATION 6.24 | 25.81 Years STANDARD_DEVIATION 6.5 |
| Impacted full bony 3rd molars extracted | .96 teeth STANDARD_DEVIATION 1.23 | .97 teeth STANDARD_DEVIATION 1.23 | 0.98 teeth STANDARD_DEVIATION 1.22 |
| Race/Ethnicity, Customized Did Not Want to Report | 23 Participants | 51 Participants | 28 Participants |
| Race/Ethnicity, Customized Hispanic | 279 Participants | 561 Participants | 282 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 141 Participants | 272 Participants | 131 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 255 Participants | 512 Participants | 257 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 179 Participants | 357 Participants | 178 Participants |
| Race/Ethnicity, Customized Other | 32 Participants | 62 Participants | 30 Participants |
| Sex: Female, Male Female | 457 Participants | 910 Participants | 453 Participants |
| Sex: Female, Male Male | 452 Participants | 905 Participants | 453 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 909 | 0 / 906 |
| other Total, other adverse events | 58 / 909 | 51 / 906 |
| serious Total, serious adverse events | 1 / 909 | 2 / 906 |
Outcome results
Primary
Composite Pain 1
Before going to sleep participants are asked to rate their worst pain experienced, least pain experienced and average pain experienced during the day along with pain now. Upon waking participants were asked to rate their worst pain experienced, least pain experienced and average pain experienced during the night along with pain now. A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Time frame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Composite Pain 1 | 3.77 units on a scale |
| Opioid | Composite Pain 1 | 4.47 units on a scale |
Primary
Composite Pain 2
Before going to sleep participants are asked to rate their worst pain experienced, least pain experienced and average pain experienced during the day along with pain now. Upon waking participants were asked to rate their worst pain experienced, least pain experienced and average pain experienced during the night along with pain now. A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
Time frame: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Composite Pain 2 | 3.20 units on a scale |
| Opioid | Composite Pain 2 | 3.48 units on a scale |
Primary
Composite Pain 3
Before going to sleep participants are asked to rate their worst pain experienced, least pain experienced and average pain experienced during the day along with pain now. Upon waking participants were asked to rate their worst pain experienced, least pain experienced and average pain experienced during the night along with pain now. A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
Time frame: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Composite Pain 3 | 2.97 units on a scale |
| Opioid | Composite Pain 3 | 3.06 units on a scale |
Primary
Composite Pain All
Before going to sleep participants are asked to rate their worst pain experienced, least pain experienced and average pain experienced during the day along with pain now. Upon waking participants were asked to rate their worst pain experienced, least pain experienced and average pain experienced during the night along with pain now. A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Time frame: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Composite Pain All | 2.73 units on a scale |
| Opioid | Composite Pain All | 2.94 units on a scale |
Primary
Overall Satisfaction
Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: Overall, how satisfied were you with your current pain medication?
Time frame: At time of post-operative visit (day 9 +/- 5 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Non-Opioid | Overall Satisfaction | Very Satisfied | 355 Participants |
| Non-Opioid | Overall Satisfaction | Satisfied | 409 Participants |
| Non-Opioid | Overall Satisfaction | Neither satisfied nor dissatisfied | 87 Participants |
| Non-Opioid | Overall Satisfaction | Dissatisfied | 33 Participants |
| Non-Opioid | Overall Satisfaction | Very dissatisfied | 12 Participants |
| Non-Opioid | Overall Satisfaction | MIssing | 13 Participants |
| Opioid | Overall Satisfaction | Very dissatisfied | 12 Participants |
| Opioid | Overall Satisfaction | Very Satisfied | 308 Participants |
| Opioid | Overall Satisfaction | Dissatisfied | 54 Participants |
| Opioid | Overall Satisfaction | Satisfied | 395 Participants |
| Opioid | Overall Satisfaction | MIssing | 15 Participants |
| Opioid | Overall Satisfaction | Neither satisfied nor dissatisfied | 122 Participants |
Primary
Pain Average 1
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Time frame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Average 1 | 3.75 score on a scale |
| Opioid | Pain Average 1 | 4.47 score on a scale |
Primary
Pain Average 2
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Time frame: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Average 2 | 3.18 score on a scale |
| Opioid | Pain Average 2 | 3.49 score on a scale |
Primary
Pain Average 3
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Time frame: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Average 3 | 2.97 score on a scale |
| Opioid | Pain Average 3 | 3.07 score on a scale |
Primary
Pain Average All
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Time frame: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Average All | 2.69 score on a scale |
| Opioid | Pain Average All | 2.95 score on a scale |
Primary
Pain Worst 1
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Time frame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Worst 1 | 4.90 score on a scale |
| Opioid | Pain Worst 1 | 5.79 score on a scale |
Primary
Pain Worst 2
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Time frame: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Worst 2 | 4.17 score on a scale |
| Opioid | Pain Worst 2 | 4.48 score on a scale |
Primary
Pain Worst 3
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Time frame: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Worst 3 | 3.97 score on a scale |
| Opioid | Pain Worst 3 | 3.96 score on a scale |
Primary
Pain Worst All
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Time frame: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Worst All | 3.66 score on a scale |
| Opioid | Pain Worst All | 3.79 score on a scale |
Secondary
Number of Participants Receiving Rescue Medication
Participant receiving additional pain medication (oxycodone) as study analgesic is not managing pain sufficiently
Time frame: At post operative visit (9 days after surgery +/- 5 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Opioid | Number of Participants Receiving Rescue Medication | 26 Participants |
| Opioid | Number of Participants Receiving Rescue Medication | 54 Participants |
Secondary
Pain Interference 1
Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 1 is the average ratings provided at the end of the day of surgery. Lower scores are better.
Time frame: End of the day of surgery (day 1)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Interference 1 | 2.75 score on a scale |
| Opioid | Pain Interference 1 | 3.11 score on a scale |
Secondary
Pain Interference 2
Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 2 is the average ratings provided at the end of day after surgery (day 2). Lower scores are better.
Time frame: End of the first full day after surgery (day 2)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Interference 2 | 2.27 score on a scale |
| Opioid | Pain Interference 2 | 2.50 score on a scale |
Secondary
Pain Interference 3
Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 3 is the average ratings provided at the end of 2nd day after surgery (day 3). Lower scores are better.
Time frame: End of the second full day after surgery (day 3)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Interference 3 | 2.20 score on a scale |
| Opioid | Pain Interference 3 | 2.34 score on a scale |
Secondary
Pain Interference All
Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference ALL is the average ratings provided at the end of the 1st seven days after surgery (days 1 thru 7). Lower scores are better.
Time frame: First 7 days after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Pain Interference All | 2.09 score on a scale |
| Opioid | Pain Interference All | 2.21 score on a scale |
Secondary
Potential for Opioid Tablet Diversion
Number of returned opioid analgesic capsules at post operative visit (9 days after surgery +/- 5 days)
Time frame: At post operative visit (9 days after surgery +/- 5 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Potential for Opioid Tablet Diversion | 0 capsules |
| Opioid | Potential for Opioid Tablet Diversion | 8.55 capsules |
Secondary
Sleep 1
Participants were asked to rate the overall quality of their sleep the 1st night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the day after surgery.
Time frame: When first waking up the day after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Sleep 1 | 4.28 score on a scale |
| Opioid | Sleep 1 | 4.62 score on a scale |
Secondary
Sleep 2
Participants were asked to rate the overall quality of their sleep the 2nd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 2 is the rating provided when first waking up the second day after surgery.
Time frame: When first waking up the 2nd day after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Sleep 2 | 4.10 score on a scale |
| Opioid | Sleep 2 | 4.14 score on a scale |
Secondary
Sleep 3
Participants were asked to rate the overall quality of their sleep the 3rd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the third day after surgery.
Time frame: When first waking up the 3rd day after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Sleep 3 | 3.78 score on a scale |
| Opioid | Sleep 3 | 3.82 score on a scale |
Secondary
Sleep All
Participants were asked to rate the overall quality of their sleep for the first 7 nights after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep All is the average rating provided for all seven nights.
Time frame: First 7 nights after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Sleep All | 3.69 score on a scale |
| Opioid | Sleep All | 3.62 score on a scale |
Post Hoc
Satisfaction 1
Participants were asked overall, how satisfied were you with your current pain medication. Responses were provided on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) Satisfaction 1 is the average of the response provided for the day of surgery and the 1st night after surgery.
Time frame: Day of surgery (day 1) and 1 night after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Satisfaction 1 | 2.22 score on a scale |
| Opioid | Satisfaction 1 | 2.38 score on a scale |
Post Hoc
Satisfaction 2
Participants were asked overall, how satisfied were you with your current pain medication. Responses were provided on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) Satisfaction 2 is the average of the response provided for the 1st day of after surgery (day 2) and the 2nd night after surgery.
Time frame: Day after surgery (day 2) and 2nd night after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Satisfaction 2 | 2.17 score on a scale |
| Opioid | Satisfaction 2 | 2.27 score on a scale |
Post Hoc
Satisfaction 3
Participants were asked overall, how satisfied were you with your current pain medication. Responses were provided on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) Satisfaction 3 is the average of the response provided for the 2nd day of after surgery (day 3) and the 3nd night after surgery.
Time frame: Second day after (day 3) and third night after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Satisfaction 3 | 2.21 score on a scale |
| Opioid | Satisfaction 3 | 2.30 score on a scale |
Post Hoc
Satisfaction All
Participants were asked overall, how satisfied were you with your current pain medication. Responses were provided on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) Satisfaction ALL is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Time frame: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Opioid | Satisfaction All | 2.24 score on a scale |
| Opioid | Satisfaction All | 2.27 score on a scale |