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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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date February 17, 2021
Est. primary completion date February 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Norton Healthcare Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Norton Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Cumulative Morphine Milligram Equivalents at 24 hours Cumulative Morphine Milligram Equivalents consumed at 24 hours 24 hours
Secondary Cumulative Morphine Milligram Equivalents at 48 hours Cumulative Morphine Milligram Equivalents consumed at 48 hours 48 hours
Secondary Cumulative Morphine Milligram Equivalents at 72 hours Cumulative Morphine Milligram Equivalents consumed at 72 hours 72 hours
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