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Postoperative Pain Control in Total Shoulder Arthroplasty

Primary Purpose

Total Shoulder Arthroplasty

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine
Sponsored by
Scripps Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Shoulder Arthroplasty

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty

Exclusion Criteria:

  • Patients under the age of 50 years
  • Patients over the age of 85
  • Patients undergoing a revision shoulder procedure
  • Documented drug or alcohol abuse
  • Active narcotic use within 3 months prior to surgery
  • Neurological deficit
  • Allergy to amide anesthetics
  • Oxycodone intolerance
  • Unable to take Celebrex
  • Enrollment in another clinical trial
  • Comorbidity that is contraindicated with the administration of an interscalene block
  • Cognitive or mental health status that interferes with study

Sites / Locations

  • Scripps ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine [133mg].

The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.

Outcomes

Primary Outcome Measures

Narcotic usage
Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents)

Secondary Outcome Measures

Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)
Patients' self-reported pain severity and impact on functioning as measured on the Brief Pain Inventory Short-Form modified survey
Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively
Patients' self-reported pain as measured on the Numeric Rating Scale
American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively
The ASES score is a 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. A score of 0 indicates the worst shoulder condition and a score of 100 indicates the best shoulder condition.
Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)
Patients' satisfaction with results of surgery as measured on the Self-Administered Patient Satisfaction Scale
Non narcotic pain medication usage
Number and type of non-narcotic pain pills consumed during the first postoperative week

Full Information

First Posted
July 21, 2021
Last Updated
September 30, 2021
Sponsor
Scripps Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05068960
Brief Title
Postoperative Pain Control in Total Shoulder Arthroplasty
Official Title
A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia With and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Clinic

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.
Detailed Description
In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks. This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double Blinded Randomized Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients will be blinded. Surgeon, nurses, and other clinical care providers will be blinded. Research staff will be blinded. The only staff who knows study group assignment is the pharmacist and the anesthesiologist and preoperative nurse who will administer the interscalene block.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine [133mg].
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Interscalene block with bupivacaine for pain control following total shoulder arthroplasty
Primary Outcome Measure Information:
Title
Narcotic usage
Description
Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents)
Time Frame
Postoperatively (up to 1 week)
Secondary Outcome Measure Information:
Title
Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)
Description
Patients' self-reported pain severity and impact on functioning as measured on the Brief Pain Inventory Short-Form modified survey
Time Frame
Postoperatively (at 1 week)
Title
Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively
Description
Patients' self-reported pain as measured on the Numeric Rating Scale
Time Frame
Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Title
American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively
Description
The ASES score is a 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. A score of 0 indicates the worst shoulder condition and a score of 100 indicates the best shoulder condition.
Time Frame
Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Title
Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)
Description
Patients' satisfaction with results of surgery as measured on the Self-Administered Patient Satisfaction Scale
Time Frame
Postoperatively (at 4 weeks)
Title
Non narcotic pain medication usage
Description
Number and type of non-narcotic pain pills consumed during the first postoperative week
Time Frame
Postoperatively (up to 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty Exclusion Criteria: Patients under the age of 50 years Patients over the age of 85 Patients undergoing a revision shoulder procedure Documented drug or alcohol abuse Active narcotic use within 3 months prior to surgery Neurological deficit Allergy to amide anesthetics Oxycodone intolerance Unable to take Celebrex Enrollment in another clinical trial Comorbidity that is contraindicated with the administration of an interscalene block Cognitive or mental health status that interferes with study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heinz Hoenecke, MD
Phone
858.554.7993
Email
hoenecke.heinz@scrippshealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Julie McCauley, BA
Phone
858.554.7122
Email
mccauley.julie@scrippshealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Hoenecke, MD
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie McCauley, BA
Phone
858-554-7122
Email
mccauley.julie@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Heinz Hoenecke, MD
First Name & Middle Initial & Last Name & Degree
Brian Rebolledo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain Control in Total Shoulder Arthroplasty

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