Brief Summary

Purpose of Study: To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Sep 2016

Typical duration for phase_4

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

September 1, 2016

Completed

1.7 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed

22 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

October 12, 2020

Completed

Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2.5 years

First QC Date

May 8, 2018

Results QC Date

August 28, 2020

Last Update Submit

October 9, 2020

Conditions

Opioid Use Shoulder Osteoarthritis Avascular Necrosis Rotator Cuff Tear Arthritis;Inflammatory

Keywords

Primary Total Shoulder ArthroplastyReverse Total Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

Post Op Pain
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)
24 hours

Secondary Outcomes (15)

Additional Post Op Pain
6hrs, 12hrs, 2weeks, 2 months
Nausea
2 Weeks
Constipation
2 Weeks
Falls
2 Weeks
Morphine Use
In-hospital Stay
+10 more secondary outcomes

Study Arms (2)

Observational

NO INTERVENTION

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

ACTIVE COMPARATOR

Oral dose of both gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without the aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but should include one dose of IV acetaminophen during the procedure. Anesthetic modalities will 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). As needed medications will include both oral and IV acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance.

Drug: GabapentinDrug: CelecoxibDrug: toradolDrug: acetaminophenDrug: regional blockDrug: propofolDrug: IV lidocaineDrug: rocuroniumDrug: vecuroniumDrug: sevofluraneDrug: desflurane