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The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

Primary Purpose

Rotator Cuff Tear

Status

Suspended

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

EXPAREL 1.3 % in 20 ML Injection

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Shoulder, Rotator cuff

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female
18-72 years of age
Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators

Exclusion Criteria:

Planned concomitant glenoid labral repair
Previous open shoulder surgery
Neurological deficit or other disability involving the surgical extremity
Anyone with a documented allergy to bupivicaine
Subjects that are not mentally competent to give consent
Pregnant women
Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent combination medication

Sites / Locations

Andrews Research & Education Foundation

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EXPAREL 1.3 % in 20 ML Injection

Arm Description

EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors: size of surgical site volume required to cover the area individual patient factors that may impact the safety of an amide local anesthetic maximum doe of 266 mg (20 mL)

Outcomes

Primary Outcome Measures

Daily Log of Pain Score

Daily reported patient numeric pain rating

Daily Log of Narcotic Medication Usage

Number of narcotic medication consumed

Secondary Outcome Measures

American Shoulder and Elbow Surgeons Shoulder Score (ASES)

Pain score measured utilizing patient questionnaire answers

American Shoulder and Elbow Surgeons Shoulder Score (ASES)

Function score measured utilizing patient questionnaire answers

Full Information

NCT ID

NCT03290196

First Posted

September 18, 2017

Last Updated

March 4, 2020

Sponsor

Andrews Research & Education Foundation

Collaborators

Pacira Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03290196

Brief Title

The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

Official Title

The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Suspended

Why Stopped

Patients pain was not regulated well with this product.

Study Start Date

September 3, 2015 (Actual)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Andrews Research & Education Foundation

Collaborators

Pacira Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.

Detailed Description

Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting this study, will allow the option for a surgeon to administer a local anesthetic, in a single injection, to the exact location of the surgical procedure and in a sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used as a safe alternative to current post-operative pain control methods, while limiting narcotic use and providing appropriate postoperative analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear

Keywords

Shoulder, Rotator cuff

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EXPAREL 1.3 % in 20 ML Injection

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

EXPAREL 1.3 % in 20 ML Injection

Other Intervention Name(s)

bupivacaine liposome injectable suspension

Intervention Description

EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.

Primary Outcome Measure Information:

Title

Daily Log of Pain Score

Description

Daily reported patient numeric pain rating

Time Frame

2 weeks

Title

Daily Log of Narcotic Medication Usage

Description

Number of narcotic medication consumed

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

American Shoulder and Elbow Surgeons Shoulder Score (ASES)

Description

Pain score measured utilizing patient questionnaire answers

Time Frame

2 week follow-up visit

Title

American Shoulder and Elbow Surgeons Shoulder Score (ASES)

Description

Function score measured utilizing patient questionnaire answers

Time Frame

2 week follow-up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female 18-72 years of age Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators Exclusion Criteria: Planned concomitant glenoid labral repair Previous open shoulder surgery Neurological deficit or other disability involving the surgical extremity Anyone with a documented allergy to bupivicaine Subjects that are not mentally competent to give consent Pregnant women Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent combination medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James R Andrews, MD

Organizational Affiliation

Andrews Institute for Orthopaedics & Sports Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Andrews Research & Education Foundation

City

Gulf Breeze

State/Province

Florida

ZIP/Postal Code

32561

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

2131867

Citation

Johnson MD, Mickler T, Arthur GR, Rosenburg S, Wilson R. Bupivacaine with and without epinephrine for intercostal nerve block. J Cardiothorac Anesth. 1990 Apr;4(2):200-3. doi: 10.1016/0888-6296(90)90238-b.

Results Reference

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PubMed Identifier

16088895

Citation

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Results Reference

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PubMed Identifier

22266897

Citation

Bergese SD, Onel E, Morren M, Morganroth J. Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):145-51. doi: 10.1097/AAP.0b013e31823d0a80.

Results Reference

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PubMed Identifier

24817851

Citation

Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014 Apr 30;5:90. doi: 10.3389/fphar.2014.00090. eCollection 2014.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

25018650

Citation

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Results Reference

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PubMed Identifier

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Citation

Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.

Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

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