Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exparel for Total Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04364867
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Norton Healthcare

Brief 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.


Condition or disease Intervention/treatment Phase
Total Shoulder Arthroplasty Drug: Exparel Drug: Pain Pump Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Exparel vs Pain Pump for Post-operative Pain Control After Total Shoulder Arthroplasty
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

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.




Primary Outcome Measures :
  1. Pain score in the 24 hours after surgery [ Time Frame: 24 hours after surgery ]
    Worst pain score (0 [none] to 10 [worst possible]) in the 24 hours after surgery


Secondary Outcome Measures :
  1. Pain score in the 48 hours after surgery [ Time Frame: 48 hours ]
    Worst pain score (0 [none] to 10 [worst possible]) in the 48 hours after surgery

  2. Pain score in the 72 hours after surgery [ Time Frame: 72 hours ]
    Worst pain score (0 [none] to 10 [worst possible]) in the 72 hours after surgery

  3. Cumulative Morphine Milligram Equivalents at 24 hours [ Time Frame: 24 hours ]
    Cumulative Morphine Milligram Equivalents consumed at 24 hours

  4. Cumulative Morphine Milligram Equivalents at 48 hours [ Time Frame: 48 hours ]
    Cumulative Morphine Milligram Equivalents consumed at 48 hours

  5. Cumulative Morphine Milligram Equivalents at 72 hours [ Time Frame: 72 hours ]
    Cumulative Morphine Milligram Equivalents consumed at 72 hours



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364867


Contacts
Layout table for location contacts
Contact: Ryan Krupp, MD 502-394-6341 ryan.krupp@nortonhealthcare.org
Contact: Leah Carreon, MD, MSc 502-992-0488 ext 14139 leah.carreon@nortonhealthcare.org

Locations
Layout table for location information
United States, Kentucky
Norton Healthcare
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Norton Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Ryan Krupp, MD Norton Healthcare
Layout table for additonal information
Responsible Party: Norton Healthcare
ClinicalTrials.gov Identifier: NCT04364867    
Other Study ID Numbers: 20-N0122
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Norton Healthcare:
Total Shoulder Arthroplasty
Post-operative Pain
Pain pump
Liposomal Bupivacaine