Exparel for Total Shoulder Arthroplasty

Randomized Clinical Trial of Exparel vs Pain Pump for Post-operative Pain Control After Total Shoulder Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Total Shoulder Arthroplasty
• Intervention / Treatment: Drug: Exparel; Drug: Pain Pump

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exparel; Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine	Drug: Exparel; Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine
Active Comparator: Pain pump; 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.	Drug: Pain Pump; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score in the 24 hours after surgery	Worst pain score (0 [none] to 10 [worst possible]) in the 24 hours after surgery	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score in the 48 hours after surgery	Worst pain score (0 [none] to 10 [worst possible]) in the 48 hours after surgery	48 hours
Pain score in the 72 hours after surgery	Worst pain score (0 [none] to 10 [worst possible]) in the 72 hours after surgery	72 hours
Cumulative Morphine Milligram Equivalents at 24 hours	Cumulative Morphine Milligram Equivalents consumed at 24 hours	24 hours
Cumulative Morphine Milligram Equivalents at 48 hours	Cumulative Morphine Milligram Equivalents consumed at 48 hours	48 hours
Cumulative Morphine Milligram Equivalents at 72 hours	Cumulative Morphine Milligram Equivalents consumed at 72 hours	72 hours

Collaborators and Investigators

• Sponsor: Norton Healthcare
• Investigators: Principal Investigator: Ryan Krupp, MD, Norton HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): February 17, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Liposomal Bupivacaine; Total Shoulder Arthroplasty; Post-operative Pain; Pain pump
• Other Study ID Numbers: 20-N0122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No