Effective Pain Management During Shoulder Replacement Surgery With EXPAREL

February 24, 2021 updated by: TriHealth Inc.

Effective Pain Management During Shoulder Replacement Surgery With Either Continuous Ropivacaine Interscalene Nerve Block or Local Infiltration With EXPAREL After Single Shot Injection Ropivacaine Interscalene Nerve Block

The purpose of this study is to examine the effectiveness of post-operative pain control of local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of pain that may require opioid consumption for several days post-operatively. The side effects of opioids are numerous, and ropivacaine administered pre-operatively via interscalene nerve block, with a post-operative continuous ropivacaine infusion through an indwelling catheter (CINB) is a highly effective method for controlling pain and reducing opioid consumption and side effects. While CINB provides adequate post-operative analgesia, and may extend post-operative pain relief for up to 48 hours, there are some risks associated with CINB ranging from catheter tip withdrawal to more serious complications including catheter tip beakage, brachial plexus injury, and pulmonary complications. Local infiltration of liposomal bupivacaine (EXPAREL Pacira Pharmaceuticals, Inc., Parsippany, New Jersey) may provide longer-lasting pain relief when compared to single shot INB (SSINB), and reduce opioid consumption at 24 hours, 48 hours and 72 hours post-op. Studies have shown inconsistency in the effectiveness of EXPAREL, and one proposed reason is the method of administration. Clinicians experienced in their infiltration technique demonstrated greater improvement in pain-related outcomes. The first 48 hours post-op present the most likely opportunity for reducing narcotic administration, which increases the value of attempting to reduce opioid consumption during this period. The cost of EXPAREL LIA, is slightly less than the cost of CINB, and if pain control is comparable, may benefit the patient in reducing hospital costs. The purpose of this study is to examine the effectiveness of pain control of local infiltration of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samarian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical candidate for primary total shoulder replacement or reverse total shoulder replacement
  • Patient must be 18 years or older
  • Patient must be willing and able to sign IRB approved informed consent form, and must be able to understand and agree to follow study protocol.

Exclusion Criteria:

  • Severe bronchopulmonary disease
  • Oxygen dependent
  • Existing nerve injury
  • BMI > 40
  • Coagulation disorders
  • Allergy to ropivicaine or bupivacaine
  • History of drug or alcohol abuse
  • Opioid use within 3 days prior to surgery
  • ASA physical status > lll
  • Discharge plan to Skilled nursing facility
  • Pregnant women
  • Non-English speaking patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EXPAREL
Those patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue.
Drug: local infiltration of liposomal bupivacaine
Those patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue.
ACTIVE_COMPARATOR: interscalene nerve block
Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer.
Other: continuous infusion of ropivacaine interscalene nerve block

All patients will receive a single injection of 30mL, 0.5% preservative-free ropivacaine.

Those patients randomized to receive CINB will then have an indwelling catheter placed and held in place by Dermabond and Tegaderm. Placement will be confirmed by ultrasound. Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: post-operative day 1
Opioid consumption in morphine equivalents within the first 24 hours post-operatively.
post-operative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 17, 2018

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (ACTUAL)

March 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared with other researchers. De-identified results will be shared via publication, and conference.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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