Shoulder Surgery
Conditions
Brief summary
To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents.
Detailed description
This is a single center, investigator initiated, prospective, randomized, controlled trial conducted among patients who have given voluntary consent to participate. Participation will last until the completion of the twelve weeks standard of care follow up visit.
Interventions
DEVICECryotherapy
see opiate sparing description
Sponsors
Campbell Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Primary shoulder arthroplasty * 18-85 years of age * Body Mass Index greater than or equal to 45 * Willing and able to provide written informed consent * Willing and able to cooperative in the required postoperative therapy * Willing and able to complete scheduled follow-up evaluations * Fluent in verbal and written English
Exclusion criteria
* Less than 18 years or over 85 years of age * Unable to provide written informed consent, cooperate with postoperative therapy, or complete follow-up evaluations * Known sensitivity, allergy, or intolerance to medications with protocols * Renal disease as defined by active or impending dialysis within six months or kidney transplant * Concomitant ipsilateral upper extremity injury or condition other than shoulder that compromises function * Chronic pain syndrome * Five consecutive days of opiate use with the previous ninety days * Worker's compensation claim * Women who are pregnant, planning to become to become pregnant, or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Score (VAS) at Week 2 | postoperative day fourteen (two weeks) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Opioid Pain Pills Taken | Post-operative Day 1 through 12 weeks | The total number of opioid pain pills consumed from post-operative day 1 to Week 12 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| 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 | 42 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Follow-up visits completed outside of window | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Opiate Sparing | Opiate Based | Total |
|---|---|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 6.6 | 72.4 years STANDARD_DEVIATION 5.4 | 72.24 years STANDARD_DEVIATION 5.9 |
| Body Mass Index | 30.5 kg/m^2 STANDARD_DEVIATION 4.1 | 30.2 kg/m^2 STANDARD_DEVIATION 6.3 | 30.36 kg/m^2 STANDARD_DEVIATION 5.4 |
| Race/Ethnicity, Customized Other Race | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White Race | 34 Participants | 40 Participants | 74 Participants |
| Sex: Female, Male Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Male | 20 Participants | 27 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 1 / 42 |
| other Total, other adverse events | 2 / 36 | 1 / 42 |
| serious Total, serious adverse events | 0 / 36 | 0 / 42 |
Outcome results
Primary
Visual Analog Score (VAS) at Week 2
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).
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opiate Sparing | Visual Analog Score (VAS) at Week 2 | 1.4 score on a scale | Standard Deviation 1.7 |
| Opiate Based | Visual Analog Score (VAS) at Week 2 | 1.8 score on a scale | Standard Deviation 2.3 |
Secondary
Number of Opioid Pain Pills Taken
The total number of opioid pain pills consumed from post-operative day 1 to Week 12
Time frame: Post-operative Day 1 through 12 weeks
Population: All patients that completed surgery, received their assigned intervention, and completed all follow-up visits within the study window.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opiate Sparing | Number of Opioid Pain Pills Taken | 4.3 opioid pain pills | Standard Deviation 11.9 |
| Opiate Based | Number of Opioid Pain Pills Taken | 17.0 opioid pain pills | Standard Deviation 19.6 |