Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04364867 |
Other study ID # |
20-N0122 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
August 12, 2020 |
Est. completion date |
February 17, 2021 |
Study information
Verified date |
February 2022 |
Source |
Norton Healthcare |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The primary objective of this study is to determine if Exparel leads to better pain scores at
24, 48 and 73 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.
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.