Exparel for Total Shoulder Arthroplasty

NCT04364867 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20-N0122
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Shoulder Arthroplasty

Keywords

Total Shoulder Arthroplasty; Post-operative Pain; Pain pump; Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain Score in the 48 Hours After Surgery

  48 hours

• Cumulative Morphine Milligram Equivalents at 24 Hours

  24 hours

• Cumulative Morphine Milligram Equivalents at 48 Hours

  48 hours

• Cumulative Morphine Milligram Equivalents at 72 Hours

  72hours

• Pain Score in the 72 Hours After Surgery

  72 hours

Study Arms (2)

Exparel

EXPERIMENTAL

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

Drug: Exparel

Pain pump

ACTIVE COMPARATOR

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.

Drug: Pain Pump

Interventions

Exparel DRUG

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

Exparel

Pain Pump DRUG

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.

Pain pump

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norton Healthcare: lead

Study Sites (1)

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Ryan Krupp MD
• Organization: Orthopedic Institute, Norton Healthcare

Ryan.Krupp@nortonhealthcare.org

502-394-6341

Study Officials

• Ryan Krupp, MD

  Norton Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: August 12, 2020
• Primary Completion: February 8, 2021
• Study Completion: February 17, 2021
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)