Trial Outcomes & Findings for Opioid-Free Shoulder Arthroplasty (NCT NCT03540030)

NCT ID: NCT03540030

Last Updated: 2020-10-14

Results Overview

Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 86 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2020-10-14

Participant Flow

Patients were identified in clinic by the surgeon performing the shoulder arthroplasty. The surgeon introduced the concept of opioid-free arthroplasty with the patients, who then chose whether to follow the traditional or opioid-free pathway. The surgeon then notified the study coordinator of the patient's decision and patients were consented.

Participant milestones

Measure	Observational The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Overall Study STARTED	48	38
Overall Study COMPLETED	30	35
Overall Study NOT COMPLETED	18	3

Reasons for withdrawal

Measure	Observational The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Overall Study Withdrawal by Subject	2	1
Overall Study screen fail	7	1
Overall Study never had surgery after signing consent	9	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.	Total n=65 Participants Total of all reporting groups
Age, Continuous	72.5 years n=30 Participants	71.1 years n=35 Participants	72.0 years n=65 Participants
Sex: Female, Male Female	20 Participants n=30 Participants	18 Participants n=35 Participants	38 Participants n=65 Participants
Sex: Female, Male Male	10 Participants n=30 Participants	17 Participants n=35 Participants	27 Participants n=65 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 participants n=30 Participants	35 participants n=35 Participants	65 participants n=65 Participants

PRIMARY outcome

Timeframe: 24 hours

Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain)

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Post Op Pain	3.0 score on a scale Interval 1.0 to 5.0	2.0 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 6hrs, 12hrs, 2weeks, 2 months

post-operative pain: measured on a 0 (no pain) -10 (worst) numeric rating scale (NRS) at 6hrs, 12hrs, 2 weeks, and 2 months. A score of 0(no pain) is preferable to 10(worst possible pain)

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Additional Post Op Pain 6 Hrs	2 score on a scale Interval 0.0 to 3.5	0.0 score on a scale Interval 0.0 to 0.0
Additional Post Op Pain 12 hrs	4 score on a scale Interval 1.0 to 7.0	0 score on a scale Interval 0.0 to 3.0
Additional Post Op Pain 2 weeks	1.3 score on a scale Interval 0.0 to 4.6	0.82 score on a scale Interval 0.0 to 3.0
Additional Post Op Pain 2 months	0.7 score on a scale Interval 0.0 to 2.9	0 score on a scale Interval 0.0 to 1.4

SECONDARY outcome

Timeframe: 2 Weeks

rate of nausea

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Nausea Yes	5 Participants	1 Participants
Nausea No	23 Participants	34 Participants
Nausea Unknown	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 Weeks

rate of constipation

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Constipation Yes	19 Participants	13 Participants
Constipation No	9 Participants	22 Participants
Constipation Unknown	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 Weeks

rate of falls

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Falls Yes	1 Participants	5 Participants
Falls No	27 Participants	30 Participants
Falls Unknown	2 Participants	0 Participants

SECONDARY outcome

Timeframe: In-hospital Stay

Morphine milli-equivalents In-hospital post-operative. Continuous scale of MME, no defined better/worse. Measured as number and dose of medications taken. For example, if the patient received an opioid, the drug and dose was recorded and converted to MME. A time frame of when to assess opioid use in-hospital post-operative was not used but was a continuous monitor for rescue opioid from in-hospital post-operative through discharge.

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Morphine Use	45.0 Morphine milli-equivalents Interval 34.0 to 66.0	19.0 Morphine milli-equivalents Interval 19.0 to 19.0

SECONDARY outcome

Timeframe: 2 Weeks

Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Pain Satisfaction Yes	27 Participants	34 Participants
Pain Satisfaction No	1 Participants	1 Participants
Pain Satisfaction Unknown	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 Weeks

American Shoulder and Elbow Surgeons (ASES) Shoulder Score for pain and function. Range 0-100. Low score = worse shoulder condition. Function, disability, and pain subscores (all ranges 0-50), and are summed for total ASES score.

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
ASES	54.3 units on a scale Interval 50.2 to 62.9	54.2 units on a scale Interval 46.7 to 60.0

SECONDARY outcome

Timeframe: 2 Weeks

Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Simple Shoulder Test	2.0 score on a scale Interval 1.5 to 4.0	2.0 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 2 Weeks

quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore MCS	56.3 score on a scale Interval 50.2 to 62.9	59.1 score on a scale Interval 52.5 to 64.1
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore PCS	36.7 score on a scale Interval 28.3 to 43.9	35.0 score on a scale Interval 29.1 to 43.7

SECONDARY outcome

Timeframe: 2 Months

rate of nausea

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Nausea Yes	0 Participants	1 Participants
Nausea No	28 Participants	30 Participants
Nausea Unknown	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 Months

rate of constipation

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Constipation Yes	7 Participants	4 Participants
Constipation No	21 Participants	27 Participants
Constipation Unknown	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 Months

rate of falls

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Falls Yes	4 Participants	4 Participants
Falls No	24 Participants	27 Participants
Falls Unknown	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 Months

Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Pain Satisfaction Yes	23 Participants	29 Participants
Pain Satisfaction No	5 Participants	2 Participants
Pain Satisfaction Unknown	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 Months

Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Simple Shoulder Test	6 score on a scale Interval 4.0 to 9.0	6 score on a scale Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: 2 Months

quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.

Outcome measures

Measure	Observational n=30 Participants The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=35 Participants Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore PCS	38.4 score on a scale Interval 29.6 to 44.9	40.3 score on a scale Interval 33.8 to 47.0
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore MCS	58.7 score on a scale Interval 47.6 to 62.7	60.8 score on a scale Interval 49.4 to 64.0

Adverse Events

Observational

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Opioid Intervention

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Observational n=48 participants at risk The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon.	Non-Opioid Intervention n=38 participants at risk Oral dose of gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but included one dose of IV acetaminophen during procedure. Anesthetic modalities include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). PRN medications will include acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.
Gastrointestinal disorders Hospitalization for ileus	0.00% 0/48 • Adverse event data was collected from the time of study treatment (surgery) through the end of subject participation (1 year postoperative visit).	2.6% 1/38 • Number of events 1 • Adverse event data was collected from the time of study treatment (surgery) through the end of subject participation (1 year postoperative visit).
Blood and lymphatic system disorders DVT and pulmonary embolism	2.1% 1/48 • Number of events 1 • Adverse event data was collected from the time of study treatment (surgery) through the end of subject participation (1 year postoperative visit).	0.00% 0/38 • Adverse event data was collected from the time of study treatment (surgery) through the end of subject participation (1 year postoperative visit).
Gastrointestinal disorders mesenteric artery stenosis	0.00% 0/48 • Adverse event data was collected from the time of study treatment (surgery) through the end of subject participation (1 year postoperative visit).	2.6% 1/38 • Number of events 1 • Adverse event data was collected from the time of study treatment (surgery) through the end of subject participation (1 year postoperative visit).

Other adverse events

Adverse event data not reported

Additional Information

Susan Odum

OrthoCarolina Research Institute

Phone: 7049457710

Email: susan.odum@orthocarolina.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place