Exparel for Total Shoulder Arthroplasty

Sponsor
Norton Healthcare (Other)
Overall Status
Completed
CT.gov ID
NCT04364867
Collaborator
(none)
54
1
2
6.2
8.7

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 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
Actual Study Start Date :
Aug 12, 2020
Actual Primary Completion Date :
Feb 8, 2021
Actual Study Completion Date :
Feb 17, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pain score in the 24 hours after surgery [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 [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 [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 [24 hours]

    Cumulative Morphine Milligram Equivalents consumed at 24 hours

  4. Cumulative Morphine Milligram Equivalents at 48 hours [48 hours]

    Cumulative Morphine Milligram Equivalents consumed at 48 hours

  5. Cumulative Morphine Milligram Equivalents at 72 hours [72 hours]

    Cumulative Morphine Milligram Equivalents consumed at 72 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Norton Healthcare Louisville Kentucky United States 40202

Sponsors and Collaborators

  • Norton Healthcare

Investigators

  • Principal Investigator: Ryan Krupp, MD, Norton Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norton Healthcare
ClinicalTrials.gov Identifier:
NCT04364867
Other Study ID Numbers:
  • 20-N0122
First Posted:
Apr 28, 2020
Last Update Posted:
Mar 7, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Mar 7, 2022