Clinical trial NCT04364867
Conditions: Total Shoulder Arthroplasty
Keywords: Total Shoulder Arthroplasty Post-operative Pain Pain pump Liposomal Bupivacaine
Sponsor: Norton Healthcare
Start date: 2020-08-12; Completion date: 2021-02-17
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 72 hours after Total Shoulder Arthroplasty (TSA) compared to a pain pump. Secondary objectives are (1) to determine if patients on Exparel use less narcotics and (2) have earlier return of functional use of the involved arm after surgery compared to the pain pump and (3) if use of Exparel leads to cost savings

METHODS

Sample size:

Based on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours after surgery was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of 0.05, beta of 0.80, a sample size of 51 subjects in each group will be required. To account for drop-outs, a total of 60 subjects in each arm will be enrolled.

Inclusion criteria Patients undergoing unilateral primary TSA or reverse TSA Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse reaction to medications to be administered On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone) Home Oxygen requirement whether as needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥ 50 Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using sealed envelopes

Treatment arms:

Control: Pain catheter based pain control. Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out.

Interventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine

Both arms will receive the same multimodal analgesia medications preoperatively. Celebrex 400mg PO, Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated.

Detailed description:
The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 73 hours after TSA compared to a pain pump. Secondary objectives are (1) to determine if patients on Exparel use less narcotics and (2) have earlier return of functional use of the involved arm after surgery compared to the pain pump and (3) if use of Exparel leads to cost savings

METHODS

Sample size:

Based on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours after surgery was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of 0.05, beta of 0.80, a sample size of 51 subjects in each group will be required. To account for drop-outs, a total of 60 subjects in each arm will be enrolled.

Inclusion criteria Patients undergoing unilateral primary TSA or reverse TSA Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse reaction to medications to be administered On long-acting narcotic pain medication (including extended release narcotic pain medications and methadone) Home Oxygen requirement whether as needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥ 50 Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using sealed envelopes

Treatment arms:

Control: Pain catheter based pain control. Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out.

Interventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine

Both arms will receive the same multimodal analgesia medications preoperatively. Celebrex 400mg PO, Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated.

Arms: arm 1: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine arm 2: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out.
Interventions: intervention 1: Exparel intervention 2: Pain Pump
Intervention descriptions: intervention 1: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine intervention 2: Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit infusing at 4cc/hr. The patient will go home with that device until it runs out.

Protocol documents:
Prot_SAP_001.pdf: 
Exparel RCT TSA Protocol 24MAR2020 
 
Page 1 of 3 
 
Randomized Clinical Trial of Exparel vs Pain Pump for Post-operative Pain Control after Total Shoulder 
Arthroplasty  
 
INTRODUCTION 
Routine anesthetic care for patients undergoing a Total Shoulder Arthroplasty (TSA) at our institution 
includes the implantation of a pain pump.  A pain pump is used to allow pain control in the days after a 
TSA. Anecdotally patients complain of breakthrough pain the night after their surgery when the local 
anesthetic administered during surgery starts wearing off [Abdallah].  
 
Exparel (Bupivacaine liposome injectable suspension), a sustained-release preparation of bupivacaine 
that is FDA approved for administration at the surgical site, may provide a lower-cost alternative to a 
pain pump, as it has the potential for activity up to 72 hours after surgery [Davidovitch, Golf, Haas]. Two 
prior randomized clinical controlled trials have compared Exparel to an intraoperative interscalene block 
and showed improved pain scores and less opioid consumption at 24 hours after surgery. There have 
been no studies comparing Exparel to a pain pump and evaluated the outcomes beyond 24 hours after 
surgery. 
 
The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 73 
hours after TSA compared to a pain pump.  Secondary objectives are (1) to determine if patients on 
Exparel use less narcotics and (2) have earlier return of functional use of the involved arm after surgery 
compared to the pain pump.  
 
METHODS 
Sample size:  
Based on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours after surgery 
was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of 0.05, beta of 0.80, a sample 
size of 51 subjects in each group will be required.  To account for drop-outs, a total of 60 subjects in 
each arm will be enrolled. 
 
Inclusion criteria 
 
Patients undergoing unilateral primary TSA or reverse TSA 
 
Indication for surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable 
rotator cuff tears 
 
Surgery performed by the Principal Investigator (Dr. Krupp) 
 
Anesthesia administered by Co-Principal Investigator (Dr. Perkins) 
 
Willing and able to sign an Informed Consent 
Exclusion criteria 
 
Indication for surgery is fracture 
 
Comorbid psychiatric diagnosis requiring therapy and/or medication except anxiety or 
depression 
 
Comorbid chronic pain syndrome (reflex sympathetic dystrophy, fibromyalgia) 
 
Has hepatic disease 
 
On workers compensation/disability/litigation  
 
Known adverse reaction to medications to be administered 


Exparel RCT TSA Protocol 24MAR2020 
 
Page 2 of 3 
 
 
 On long-acting narcotic pain medication (including extended release narcotic pain 
medications and methadone) 
 
Home Oxygen requirement whether PRN or scheduled. 
 
Contralateral Phrenic Nerve paralysis / incompetence. 
 
BMI ≥ 50 
 
 
Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using sealed 
envelopes 
 
Treatment arms: 
Control: Pain catheter based pain control.  Subject will receive an interscalene block with Ropivicaine 
0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr.  The patient will go home 
with that device until it runs out. 
Interventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine 
 
Both arms will receive the same multimodal analgesia medications preoperatively.  Celebrex 400mg PO, 
Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated. 
 
Variables collected 
Pre-operative 
Age 
Sex 
Race/Ethnicity 
Educational Level 
Height 
Weight 
Side of Arthroplasty 
Current pain medication 
Pain (NRS, 10 to 10) 
ASES 
SANE 
Work status 
Annual income 
Days off work 
 
In Hospital 
ASA score 
Local anesthesia start time 
Local anesthesia end time 
Operative time 
Length of hospital stay 
Cumulative MMEs consumed at 24, 48 and 72 hours 
Worst pain in past 24 hours at 24, 48 and 72 hours post-op 
Duration of sleep 


Exparel RCT TSA Protocol 24MAR2020 
 
Page 3 of 3 
 
Intraoperative complications 
Postoperative complications 
Pump failure (Yes/No) queried at 24, 48 and 72 hours 
Catheter migration (Yes/No) queried at 24, 48 and 72 hours 
Functionality of surgical arm at 24, 48 and 72 hours 
Unable to use, Only light activity, Able to do some activities, Able to do most activities, Slight 
restrictions only, Normal 
 
Six weeks post-operative 
Current pain 
ASES 
SANE 
Complications 
 
Three months post-operative 
Readmissions 
Visits to the Emergency Room 
Total costs for Index surgery and all readmissions and Emergency Room Visits 
Date returned to work 
 
 
Statistics: 
Baseline data will be compared 
ANCOVA or GEE to examine differences in worst pain scores over 24 hours over time between the two 
groups (among the three groups)