Trial Outcomes & Findings for Opioid-Free Pain Protocol After Shoulder Arthroplasty (NCT NCT05488847)
NCT ID: NCT05488847
Last Updated: 2026-02-10
Results Overview
Patients record pain levels using a Visual analog scale for 10 days post-operatively. On each day, patients report their pain level via an automated text messaging service in the morning, afternoon, and the evening. A mean pain level is calculated from all scores reported by a patient in the first 10 days postoperatively. Patients will use a 0-10 scale along with visuals to indicate their level of pain with 0 being no pain at all and 10 being the worst pain possible. Lower scores indicate better outcomes.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
The first 10 days postoperatively
Results posted on
2026-02-10
Participant Flow
Participants were assessed for eligibility and recruited for participation at their final preoperative clinic visit. Informed, written consent was obtained for eligible participants. Of 268 participants assessed for eligibility, 83 were included in the study. Of the 185 excluded participants, 69 declined participation while 116 met one of the exclusion criteria.
Included participants were not differentiated based on any factors before being randomized to a treatment group. Participant assignment to 1 of 2 treatment groups was performed using a computer generated random number sequence.
Unit of analysis: Shoulder
Participant milestones
| Measure |
Non-opioid, Multimodal Protocol
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Overall Study
STARTED
|
41 41
|
42 42
|
|
Overall Study
COMPLETED
|
38 38
|
40 40
|
|
Overall Study
NOT COMPLETED
|
3 3
|
2 2
|
Reasons for withdrawal
| Measure |
Non-opioid, Multimodal Protocol
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Opioid-Free Pain Protocol After Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
Non-opioid, Multimodal Protocol
n=38 Participants
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 Participants
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=41 Participants
|
69 years
n=1581 Participants
|
70 years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
36 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=41 Participants
|
22 Participants
n=1581 Participants
|
42 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=41 Participants
|
33 Participants
n=1581 Participants
|
64 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
BMI
|
29.9 kg/m^2
n=41 Participants
|
29.1 kg/m^2
n=1581 Participants
|
29.9 kg/m^2
n=4626 Participants
|
|
Procedure Type
TSA
|
2 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Procedure Type
RTSA
|
35 Participants
n=41 Participants
|
34 Participants
n=1581 Participants
|
69 Participants
n=4626 Participants
|
|
tobacco use
Never
|
26 Participants
n=41 Participants
|
25 Participants
n=1581 Participants
|
51 Participants
n=4626 Participants
|
|
tobacco use
Former
|
11 Participants
n=41 Participants
|
13 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
tobacco use
Current
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Diabetes status
Yes
|
8 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
17 Participants
n=4626 Participants
|
|
Diabetes status
No
|
30 Participants
n=41 Participants
|
31 Participants
n=1581 Participants
|
61 Participants
n=4626 Participants
|
|
Insulin dependence status
Yes
|
3 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Insulin dependence status
no
|
35 Participants
n=41 Participants
|
35 Participants
n=1581 Participants
|
70 Participants
n=4626 Participants
|
|
hypertension
yes
|
26 Participants
n=41 Participants
|
25 Participants
n=1581 Participants
|
51 Participants
n=4626 Participants
|
|
hypertension
no
|
12 Participants
n=41 Participants
|
15 Participants
n=1581 Participants
|
27 Participants
n=4626 Participants
|
|
chronic kidney disease
yes
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
chronic kidney disease
no
|
36 Participants
n=41 Participants
|
39 Participants
n=1581 Participants
|
75 Participants
n=4626 Participants
|
|
Worker's compensation
Yes
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Worker's compensation
No
|
37 Participants
n=41 Participants
|
40 Participants
n=1581 Participants
|
77 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: The first 10 days postoperativelyPopulation: Loss to follow-up
Patients record pain levels using a Visual analog scale for 10 days post-operatively. On each day, patients report their pain level via an automated text messaging service in the morning, afternoon, and the evening. A mean pain level is calculated from all scores reported by a patient in the first 10 days postoperatively. Patients will use a 0-10 scale along with visuals to indicate their level of pain with 0 being no pain at all and 10 being the worst pain possible. Lower scores indicate better outcomes.
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Pain Levels
|
2.4 score
Standard Deviation 1.7
|
2.3 score
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: The first 10 days postoperatively.Population: loss to follow-up
The morphine milligram equivalents (MMEs) of opioids consumed will be recorded.
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Morphine Milligram Equivalents
|
0.4 morphine milligram equivalent
Standard Deviation 1.35
|
3.7 morphine milligram equivalent
Standard Deviation 5.07
|
SECONDARY outcome
Timeframe: Preoperatively, 10 days postoperatively, 6 weeks postoperatively, and 3 months postoperativelyPopulation: Loss to follow-up; participant did not fill out questionnaire
Patient-Reported Outcome Measures (PROMs) scores for upper extremity pain and how it interferes with the patients daily life. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher pain interference (worse outcomes). Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS-PI) once every night for 10 days post-operatively.
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Pain Interference
Preoperative
|
62.4 T-score
Standard Deviation 5.3
|
60.9 T-score
Standard Deviation 4.6
|
|
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Pain Interference
10 days postoperative
|
60.9 T-score
Standard Deviation 7.3
|
60.27 T-score
Standard Deviation 6.5
|
|
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Pain Interference
6 weeks postoperatively
|
58.7 T-score
Standard Deviation 7.6
|
55.7 T-score
Standard Deviation 7.5
|
|
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Pain Interference
3 months postoperatively
|
51 T-score
Standard Deviation 8.4
|
52.7 T-score
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Preoperatively, 6 weeks postoperatively, and 3 months postoperativelyPopulation: Loss to follow-up
Patient-Reported Outcome Measures (PROMs) scores for upper extremity function. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 0 - 100-point scale, with a score of 50 representing the mean of the population at large, 0 representing the minimum, and 100 representing the maximum function.
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Function
preoperative
|
30.2 T-score
Standard Deviation 5.8
|
32.6 T-score
Standard Deviation 5.7
|
|
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Function
6 weeks postoperative
|
33.5 T-score
Standard Deviation 6.7
|
32.5 T-score
Standard Deviation 6
|
|
Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Function
3 months postoperative
|
39 T-score
Standard Deviation 8.6
|
37 T-score
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Preoperatively, 6 weeks postoperatively, and 3 months postoperativelyPopulation: Loss to follow-up
Patient-Reported Outcome Measures (PROMs) scores for depression. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher increased depression (worse).
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Patient-Reported Outcomes Scores (PROMs) for Depression
3 months postoperative
|
42.2 T-score
Standard Deviation 8.3
|
45.5 T-score
Standard Deviation 7.7
|
|
Patient-Reported Outcomes Scores (PROMs) for Depression
preoperative
|
47.9 T-score
Standard Deviation 10.2
|
46 T-score
Standard Deviation 7.8
|
|
Patient-Reported Outcomes Scores (PROMs) for Depression
6 weeks postoperative
|
43.2 T-score
Standard Deviation 9.5
|
44.4 T-score
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Preoperatively, 6 weeks postoperatively, and 3 months postoperativelyPopulation: Loss to follow-up
This is a patient reported outcome measure meant to assess participant shoulder function and pain. The score ranges from 0 to 100, with 0 representing a combination of poor shoulder function and high pain burden and 100 representing a lack of shoulder pain or functional deficit. The score is obtained by combining two subscale scores which are weighted equally. The first subscale is the visual analog scale, which asks participants to rate their pain on a scale of 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the worst pain imaginable. The second subscale is the activities of daily living questionnaire. This questionnaire is composed of 10 questions, each asking about a specific activity of daily living related to shoulder function. For each question, the answer choices include: unable to do (0 points); very difficult to do (1 point); somewhat difficult (2 points); not difficult (3 points).
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
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|---|---|---|
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American Shoulder and Elbow Score
Preoperative
|
43.9 Scores on a scale
Standard Deviation 16.6
|
47.5 Scores on a scale
Standard Deviation 20
|
|
American Shoulder and Elbow Score
6 weeks postoperative
|
64 Scores on a scale
Standard Deviation 17.6
|
65.2 Scores on a scale
Standard Deviation 18.9
|
|
American Shoulder and Elbow Score
3 months postoperative
|
71.1 Scores on a scale
Standard Deviation 20.3
|
75 Scores on a scale
Standard Deviation 16.5
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SECONDARY outcome
Timeframe: preoperatively; 6 weeks postoperatively; 3 months postoperativelyPopulation: Loss to follow-up
This is a score from 0 to 100 meant to represent the level of participant shoulder function. 0 represents the most poor function, and 100 the best possible score for function. The score is determined by combining three range of motion measures and 3 questions which are answered on a scale of 0 to 10. The three range of motion measures include forward flexion, internal rotation, and external rotation. The remaining three questions are as follows: What is your average pain on a daily basis?; What is your ability to use your affected shoulder on a daily basis?; What is your average pain when lying on affected side?
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
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|---|---|---|
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Shoulder Arthroplasty Smart Score (SAS)
preoperative
|
44 Score
Standard Deviation 14.3
|
51.5 Score
Standard Deviation 10
|
|
Shoulder Arthroplasty Smart Score (SAS)
6 weeks postoperative
|
58 Score
Standard Deviation 7.7
|
60.7 Score
Standard Deviation 12.4
|
|
Shoulder Arthroplasty Smart Score (SAS)
3 months postoperative
|
70.1 Score
Standard Deviation 9.8
|
67.3 Score
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: First 10 days postoperativelyPopulation: loss to follow-up
The side effects were assessed to see whether they were present or not in the first 10 days postoperatively. They include constipation, nausea, diarrhea, upset stomach drowsiness, and loopiness
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 shoulders
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Medication Side Effects
loopiness
|
2 days affected
Standard Deviation 2.8
|
2.5 days affected
Standard Deviation 2.9
|
|
Medication Side Effects
constipation
|
1.4 days affected
Standard Deviation 2
|
2.3 days affected
Standard Deviation 2.2
|
|
Medication Side Effects
nausea
|
0.5 days affected
Standard Deviation 1
|
0.3 days affected
Standard Deviation 0.6
|
|
Medication Side Effects
diarrhea
|
0.2 days affected
Standard Deviation 0.8
|
0.1 days affected
Standard Deviation 0.3
|
|
Medication Side Effects
upset stomach
|
0.8 days affected
Standard Deviation 1.7
|
0.9 days affected
Standard Deviation 1.7
|
|
Medication Side Effects
drowsiness
|
1.4 days affected
Standard Deviation 2
|
2.3 days affected
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: To 2 years postoperativePopulation: loss to follow-up
Whether or not patients required another operation.
Outcome measures
| Measure |
Non Opioid, Multimodal Protocol
n=38 Participants
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 Participants
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
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Number of Patients Who Required Reoperation
|
0 participants
|
1 participants
|
Adverse Events
Non-opioid, Multimodal Protocol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Opioid Protocol
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-opioid, Multimodal Protocol
n=38 participants at risk
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, all participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month.
|
Opioid Protocol
n=40 participants at risk
Preoperatively, participants were treated with oral analgesics (400 mg celecoxib, 75 mg pregabalin, and 9 mg oxycodone extended-release). Intraoperatively, participants were administered 10 mg of dexamethasone and 1000 mg of acetaminophen intravenously in addition to a local periarticular injection (a solution containing 60 mg of 0.5% ropivacaine, 1 mg of epinephrine \[1 mg/mL\], and 30 mg of ketorolac). Postoperatively, participants were discharged with oral medications that consisted of 4 mg dexamethasone twice daily for 4 days (participants that had an overnight hospital stay instead received a one-time 10 mg intravenously dexamethasone dose on postoperative day 1), 75 mg pregabalin twice daily for 14 days, 2 mg tizanidine every 6 hours for 14 days, 200 mg magnesium twice daily for 14 days, 600 mg ibuprofen every 6 hours (not to exceed 3200 mg per day) for 1 month, and 975 mg acetaminophen every 8 hours (not to exceed 3000 mg per day) for 1 month. Participants were given an additional prescription for 28 pills of 5 mg oxycodone to be taken for severe pain (≥ 6 on visual analog scale \[VAS\]). Participants in this treatment group could opt for receiving a rescue opioid prescription of 28 pills of 5 mg oxycodone if they felt that their pain was not sufficiently managed (severe pain, ≥ 6 on VAS).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
acromion fracture
|
5.3%
2/38 • From enrollment until end of follow-up, up to two years postoperatively
|
5.0%
2/40 • From enrollment until end of follow-up, up to two years postoperatively
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place