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This randomized, single blinded, clinical trial aims to investigate the efficacy of a multimodal pain control regimen for shoulder arthroplasty. Patients who receive a multimodal pain control regimen alone (study group) will be compared to patients who receive a multimodal pain control regimen plus a standard prescription of an opioid containing medication (comparison group). The primary outcome is average daily Numerical Rating Scale (NRS) pain score in the first 10 days after surgery. We hypothesize that there will be no significant difference in the primary outcome between the two groups.
The United States is in the midst of an ongoing opioid crisis. In 2019, approximately 153 million opioid prescriptions were dispensed (46.7 per 100 persons) and 50,000 people died from opioid-involved overdoses. Orthopaedic and spine conditions account for 27.7% of opioid prescriptions and prior studies demonstrate that musculoskeletal pain is frequently reported by opioid abusers as their initial reason for consuming opioids. For these reasons, orthopaedic surgeons are uniquely posed to combat this crisis. Multimodal pain control is a strategy that utilizes multiple pain medications to provide analgesia. The theory behind this strategy is that agents with different mechanisms of action work synergistically to reduce pain by blocking multiple pain pathways. Several randomized controlled trials have investigated the efficacy of multimodal pain control for orthopaedic procedures, including anterior cruciate ligament reconstruction, labral repair, meniscus repair, and rotator cuff repair. In these studies, patients who received a multimodal nonopioid regimen had equivalent or better postoperative pain control compared to a standard opioid regimen. Furthermore, no severe side effects were reported in patients who received the multimodal nonopioid regimen. This randomized, single blinded, standard of care-controlled clinical trial aims to investigate the efficacy of a multimodal pain control (similar to the regimen utilized in the aforementioned studies) for controlling pain following shoulder arthroplasty. Adult patients indicated for anatomic or reverse total shoulder arthroplasty will be randomized to either the experimental or comparison group. The experimental group will receive a multimodal, non-narcotic pain control regimen consisting of Celecoxib, Pregabalin, and Tramadol preoperatively; Dexamethasone, Acetaminophen, Ropivacaine, Epinephrine, and Ketorolac intraoperatively; and Dexamethasone, Pregabalin, Tizanidine, Magnesium, Ibuprofen, and Acetaminophen postoperatively. In addition to the aforementioned multimodal pain control regimen, the comparison group will receive a standard prescription of Oxycodone to be taken as needed postoperatively. If patients in the experimental group feel their pain is uncontrolled, they have the option of calling in to request a prescription of Oxycodone. Pain, pain medication use, and medication side effects will be closely monitored for the first 10 days after surgery by having patients respond to daily automated text messages. Additionally, all study participants will complete patient-reported outcome measures (PROMs) surveys and undergo physical examination of their shoulder during routine clinic visits preoperatively and at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively. The primary outcome of this study is postoperative pain scores on the Numerical Rating Scale (NRS) for the first 10 days postoperatively. We hypothesize that there will be no significant difference between the groups with regard to the primary outcome. Secondary outcomes measured during the first 10 days postoperative include morphine milligram equivalents (MMEs) of opioids consumed, Patient-Reported Outcome Measurement Information System Pain Interference (PROMIS-PI) score at first postoperative clinic visit (7-10 days postoperatively), duration of patient reported adverse events (ie, constipation, nausea, diarrhea, upset stomach, drowsiness, loopiness), perioperative complications, and satisfaction with pain control. Secondary outcomes measured at routine postoperative clinic visits out to 2 years after surgery include postoperative complications, need for revision surgery, PROM scores (ie, PROMIS upper extremity, PROMIS PI, PROMIS D, American Shoulder and Elbow Surgeons Shoulder Score, Shoulder Arthroplasty Smart, Constant-Murley), hospital and emergency department readmission (30-day, 60-day, 90-day), duration of narcotic pain medication use shoulder strength, and shoulder range of motion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal, Non-Narcotic | Experimental | This group will be given the preoperative, intraoperative, and discharge meds described below. This group will NOT receive any opioid-containing meds. Preoperative meds: Celecoxib: 400 mg by mouth, Pregabalin: 75 mg by mouth, Tramadol: 50 mg by mouth. Intraoperative meds: Dexamethasone: 10 mg IV, Acetaminophen: 1,000 mg IV, Ropivacaine 5 mg/mL (0.5%): 300 mg local infiltration, Epinephrine 1 mg/mL (1:1000): 1 mg local infiltration, Ketorolac 30 mg/mL: 30 mg local infiltration. Discharge meds: Dexamethasone: 4 mg by mouth twice per day for 4 days (for same day discharge only), 10 mg IV on postoperative day 1 (for overnight patients only), Pregabalin: 75 mg by mouth twice per day for 14 days, Tizanidine: 2 mg by mouth every 6 hours for 14 days, Magnesium: 200 mg by mouth twice per day for 14 days, Ibuprofen: 600 mg by mouth every 6 hours not to exceed 3200 mg per day for 1 month, Acetaminophen: 975 mg by mouth every 8 hours not to exceed 3000 mg per day for 1 month. |
|
| Multimodal Plus Narcotic | Active Comparator | This group will be given the preop, intraop, and discharge meds described below. They will also be given 35 pills of oxycodone hydrochloride 5mg to be taken every 6 hours as needed at discharge. Preoperative: Celecoxib: 400 mg PO, Pregabalin: 75 mg PO, Tramadol: 50 mg PO. Intraoperative: Dexamethasone: 10 mg IV, Acetaminophen: 1,000 mg IV, Ropivacaine 5 mg/mL (0.5%): 300 mg local infiltration, Epinephrine 1 mg/mL (1:1000): 1 mg local infiltration, Ketorolac 30 mg/mL: 30 mg local infiltration. Discharge: Dexamethasone: 4 mg PO twice per day for 4 days (for same day discharge only), 10 mg IV on postop day 1 (for overnight patients only), Pregabalin: 75 mg PO twice per day for 14 days, Tizanidine: 2 mg PO every 6 hours for 14 days, Magnesium: 200 mg PO twice per day for 14 days, Ibuprofen: 600 mg PO every 6 hours not to exceed 3200 mg per day for 1 month, Acetaminophen: 975 mg PO every 8 hours not to exceed 3000 mg per day for 1 month. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | preoperative pain medication given to all patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Levels | 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. | The first 10 days postoperatively |
| Morphine Milligram Equivalents | The morphine milligram equivalents (MMEs) of opioids consumed will be recorded. | The first 10 days postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Pain Interference | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie J Muh, MD | Henry Ford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
loss to follow-up
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Levels | 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. | Loss to follow-up | Posted | Mean | Standard Deviation | score | The first 10 days postoperatively | shoulders | shoulders |
|
From enrollment until end of follow-up, up to two years postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acromion fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Event is a complication of shoulder arthroplasty |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Muh M.D. | Henry Ford Health | 3135873854 | smuh1@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 11, 2025 | Dec 11, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000069583 | Pregabalin |
| D014147 | Tramadol |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D000082 | Acetaminophen |
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D020910 | Ketorolac |
| C023754 | tizanidine |
| D008274 | Magnesium |
| D008277 | Magnesium Oxide |
| D007052 | Ibuprofen |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Pregabalin | Drug | preoperative and discharge pain medication given to all patients |
|
|
| Tramadol | Drug | preoperative pain medication given to all patients |
|
|
| Dexamethasone | Drug | Intraoperative and discharge pain medication given to all patients |
|
|
| Acetaminophen | Drug | Intraoperative and discharge pain medication given to all patients |
|
|
| Ropivicaine | Drug | Intraoperative pain medication given to all patients |
|
|
| Epinephrine | Drug | Intraoperative pain medication given to all patients |
|
| Ketorolac | Drug | Intraoperative pain medication given to all patients |
|
| Tizanidine | Drug | Discharge pain medication given to all patients |
|
|
| Magnesium | Drug | Discharge pain medication given to all patients |
|
|
| Ibuprofen | Drug | Discharge pain medication given to all patients |
|
|
| Oxycodone Hydrochloride 5 Mg | Drug | Only given to active comparator group |
|
|
| Preoperatively, 10 days postoperatively, 6 weeks postoperatively, and 3 months postoperatively |
| Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Function | 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. | Preoperatively, 6 weeks postoperatively, and 3 months postoperatively |
| Patient-Reported Outcomes Scores (PROMs) for Depression | 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). | Preoperatively, 6 weeks postoperatively, and 3 months postoperatively |
| American Shoulder and Elbow Score | 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). | Preoperatively, 6 weeks postoperatively, and 3 months postoperatively |
| Shoulder Arthroplasty Smart Score (SAS) | 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? | preoperatively; 6 weeks postoperatively; 3 months postoperatively |
| Medication Side Effects | 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 | First 10 days postoperatively |
| Number of Patients Who Required Reoperation | Whether or not patients required another operation. | To 2 years postoperative |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Procedure Type | Type of surgery, anatomic total shoulder arthroplasty (TSA) vs reverse total shoulder arthroplasty (RTSA) | Count of Participants | Participants |
|
| tobacco use | Count of Participants | Participants |
|
| Diabetes status | Count of Participants | Participants |
|
| Insulin dependence status | Count of Participants | Participants |
|
| hypertension | Count of Participants | Participants |
|
| chronic kidney disease | Count of Participants | Participants |
|
| Worker's compensation | Is the patient paying for the surgery with a worker's compensation claim? | Count of Participants | Participants |
|
| OG001 | 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). |
|
|
|
| Secondary | Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Pain Interference | 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. | Loss to follow-up; participant did not fill out questionnaire | Posted | Mean | Standard Deviation | T-score | Preoperatively, 10 days postoperatively, 6 weeks postoperatively, and 3 months postoperatively | shoulders | shoulders |
|
|
|
| Secondary | Patient-Reported Outcomes Scores (PROMs) for Upper Extremity Function | 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. | Loss to follow-up | Posted | Mean | Standard Deviation | T-score | Preoperatively, 6 weeks postoperatively, and 3 months postoperatively | shoulders | shoulders |
|
|
|
| Secondary | Patient-Reported Outcomes Scores (PROMs) for Depression | 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). | Loss to follow-up | Posted | Mean | Standard Deviation | T-score | Preoperatively, 6 weeks postoperatively, and 3 months postoperatively | shoulders | shoulders |
|
|
|
| Secondary | American Shoulder and Elbow Score | 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). | Loss to follow-up | Posted | Mean | Standard Deviation | Scores on a scale | Preoperatively, 6 weeks postoperatively, and 3 months postoperatively | shoulders | shoulders |
|
|
|
| Primary | Morphine Milligram Equivalents | The morphine milligram equivalents (MMEs) of opioids consumed will be recorded. | loss to follow-up | Posted | Mean | Standard Deviation | morphine milligram equivalent | The first 10 days postoperatively. | shoulders | shoulders |
|
|
|
|
| Secondary | Shoulder Arthroplasty Smart Score (SAS) | 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? | Loss to follow-up | Posted | Mean | Standard Deviation | Score | preoperatively; 6 weeks postoperatively; 3 months postoperatively | shoulders | shoulders |
|
|
|
| Secondary | Medication Side Effects | 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 | loss to follow-up | Posted | Mean | Standard Deviation | days affected | First 10 days postoperatively | shoulders | shoulders |
|
|
|
|
| Secondary | Number of Patients Who Required Reoperation | Whether or not patients required another operation. | loss to follow-up | Posted | Number | participants | To 2 years postoperative |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 2 |
| 38 |
| EG001 | 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). | 0 | 40 | 0 | 40 | 2 | 40 |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D017616 | Magnesium Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
|
| 10 days postoperative |
|
|
| 6 weeks postoperatively |
|
|
| 3 months postoperatively |
|
|
|
| 6 weeks postoperative |
|
|
| 3 months postoperative |
|
|
|
| 6 weeks postoperative |
|
|
| 3 months postoperative |
|
|
|
| 6 weeks postoperative |
|
|
| 3 months postoperative |
|
|
|
| 6 weeks postoperative |
|
|
| 3 months postoperative |
|
|
| diarrhea |
|
| upset stomach |
|
| drowsiness |
|
| loopiness |
|
| Wilcoxon (Mann-Whitney) |
| 0.73 |
| Mann-Whitney |
| 0.73 |
| Equivalence |
mann-whitney U |
| Comparing the distribution of the number of days participants were affected by each side effect | Wilcoxon (Mann-Whitney) | 0.61 | Mann-Whitney | 0.61 | Equivalence | mann-whitney |
| Comparing the distribution of the number of days participants were affected by each side effect | Wilcoxon (Mann-Whitney) | 0.47 | Mann-Whitney | 0.47 | Equivalence | mann-whitney |
| Comparing the distribution of the number of days participants were affected by each side effect | Wilcoxon (Mann-Whitney) | 0.47 | mann-whitney | 0.47 | Equivalence | mann-whitney |
| Comparing the distribution of the number of days participants were affected by each side effect | Wilcoxon (Mann-Whitney) | 0.74 | Mann-Whitney | 0.74 | Equivalence | mann-whitney |