Trial Outcomes & Findings for Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty (NCT NCT04294680)
NCT ID: NCT04294680
Last Updated: 2022-12-06
Results Overview
The Visual Analog Score (VAS) is a a validated patient reported pain score with possible range from zero (no pain) to ten (worst possible pain).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
postoperative day fourteen (two weeks)
Results posted on
2022-12-06
Participant Flow
Participant milestones
| Measure |
Opiate Sparing
Cryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative
Cryotherapy: see opiate sparing description
|
Opiate Based
Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
43
|
|
Overall Study
Received Allocated Intervention
|
37
|
42
|
|
Overall Study
COMPLETED
|
36
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Opiate Sparing
Cryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative
Cryotherapy: see opiate sparing description
|
Opiate Based
Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Follow-up visits completed outside of window
|
1
|
0
|
Baseline Characteristics
Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
Opiate Sparing
n=36 Participants
Cryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative
Cryotherapy: see opiate sparing description
|
Opiate Based
n=42 Participants
Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.1 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
72.4 years
STANDARD_DEVIATION 5.4 • n=107 Participants
|
72.24 years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Race
|
34 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Body Mass Index
|
30.5 kg/m^2
STANDARD_DEVIATION 4.1 • n=99 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 6.3 • n=107 Participants
|
30.36 kg/m^2
STANDARD_DEVIATION 5.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: postoperative day fourteen (two weeks)Population: All patients that completed surgery, received their assigned intervention, and completed all follow-up visits within the study window
The Visual Analog Score (VAS) is a a validated patient reported pain score with possible range from zero (no pain) to ten (worst possible pain).
Outcome measures
| Measure |
Opiate Sparing
n=36 Participants
Cryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative
Cryotherapy: see opiate sparing description
|
Opiate Based
n=42 Participants
Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative
|
|---|---|---|
|
Visual Analog Score (VAS) at Week 2
|
1.4 score on a scale
Standard Deviation 1.7
|
1.8 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Post-operative Day 1 through 12 weeksPopulation: All patients that completed surgery, received their assigned intervention, and completed all follow-up visits within the study window.
The total number of opioid pain pills consumed from post-operative day 1 to Week 12
Outcome measures
| Measure |
Opiate Sparing
n=36 Participants
Cryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative
Cryotherapy: see opiate sparing description
|
Opiate Based
n=42 Participants
Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative
|
|---|---|---|
|
Number of Opioid Pain Pills Taken
|
4.3 opioid pain pills
Standard Deviation 11.9
|
17.0 opioid pain pills
Standard Deviation 19.6
|
Adverse Events
Opiate Sparing
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Opiate Based
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Opiate Sparing
n=36 participants at risk
Cryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative
Cryotherapy: see opiate sparing description
|
Opiate Based
n=42 participants at risk
Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Periprosthetic Fracture
|
2.8%
1/36 • Adverse events, postoperative complications, readmissions, and reoperations were recorded from day of surgery through week 12
|
2.4%
1/42 • Adverse events, postoperative complications, readmissions, and reoperations were recorded from day of surgery through week 12
|
|
Musculoskeletal and connective tissue disorders
Acromial Stress Fracture
|
2.8%
1/36 • Adverse events, postoperative complications, readmissions, and reoperations were recorded from day of surgery through week 12
|
0.00%
0/42 • Adverse events, postoperative complications, readmissions, and reoperations were recorded from day of surgery through week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place