Phase 4 N=86 Treatment

Opioid-Free Shoulder Arthroplasty

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

Bottom Line

View on ClinicalTrials.gov: NCT03540030 ↗

Enrolled (actual)

Serious AEs

3.5%

Results posted

Oct 2020

Primary outcome: Primary: Post Op Pain — 3.0; 2.0 score on a scale — p=.297

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Gabapentin (Drug); Celecoxib (Drug); toradol (Drug); acetaminophen (Drug); regional block (Drug); propofol (Drug); IV lidocaine (Drug); rocuronium (Drug); vecuronium (Drug); sevoflurane (Drug); desflurane (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: OrthoCarolina Research Institute, Inc.
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Post Op Pain	3.0; 2.0	.297
SECONDARY Additional Post Op Pain	2; 0.0; 4; 0; 1.3; 0.82	0.005 sig
SECONDARY Nausea	0; 1; 28; 30; 2; 0	>.99
SECONDARY Constipation	7; 4; 21; 27; 2; 4	0.3177
SECONDARY Falls	4; 4; 24; 27; 2; 4	>.99
SECONDARY Morphine Use	45.0; 19.0	—
SECONDARY Pain Satisfaction	23; 29; 5; 2; 2; 4	0.2349
SECONDARY ASES	54.3; 54.2	0.9669
SECONDARY Simple Shoulder Test	6; 6	0.7892
SECONDARY Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore	38.4; 40.3; 58.7; 60.8	0.2023
SECONDARY Nausea	0; 1; 28; 30; 2; 0	>.99
SECONDARY Constipation	7; 4; 21; 27; 2; 4	0.3177
SECONDARY Falls	4; 4; 24; 27; 2; 4	>.99
SECONDARY Pain Satisfaction	23; 29; 5; 2; 2; 4	0.2349
SECONDARY Simple Shoulder Test	6; 6	0.7892
SECONDARY Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore	38.4; 40.3; 58.7; 60.8	0.2023

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

Eligibility Criteria

Inclusion Criteria

Patient undergoing elective primary total shoulder or reverse total shoulder arthroplasty for osteoarthritis, avascular necrosis, cuff tear arthropathy, or inflammatory arthritis etiologies
Age greater than or equal to 50.

Exclusion Criteria

Revision total shoulder arthroplasty
Chronic opioid therapy - per investigator discretion
Liver or renal insufficiency - per investigator discretion
Arthroplasty for fracture
Sickle cell disease
Workers compensation
Inability to receive block
Intervention Arm Only: Creatinine clearance less than 30 mL/min
Intervention Arm Only: Allergy to non-steroidal anti-inflammatory medications (NSAIDs).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03540030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.