Exparel Interscalene vs Indwelling Catheter

February 12, 2023 updated by: Elilary Montilla Medrano, Montefiore Medical Center

Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study

The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

While placing an indwelling nerve catheter can prolong pain control, it can also have drawbacks and complications. While major complications like pneumothorax and hemidiaphragmatic paresis from interscalene continuous peripheral nerve blocks (CPNB) are rare, minor adverse effects associated with CPNBs may be more common. They include infection and anatomical damage to blood vessels and nerves due to the indwelling catheter. In addition, catheters take a significantly longer time to set up and place than single shot blocks, which is important as there is often a rush to block patients and trying to get them into the operating room on time. Furthermore, the needle used for catheter placement is larger than the single shot needles, which creates more discomfort to patients during the nerve block. The catheter itself is taped around the entire sides and back of the patient's neck, which is also uncomfortable for patients. Because of how shallow the interscalene block is, the catheter is often found to be dislodged from operating room positioning, patient transport or movement, which negates the placement of the catheter. An indwelling catheter must also be followed up by the acute pain service team until the catheter is removed.

Exparel, or liposomal bupivacaine, is formulated to release low dose bupivacaine over 96 hours, and was recently approved by the FDA in April 2018 to be used in interscalene blocks. The sustained release of local anesthetic could theoretically act similarly to the continuous infusion of local anesthetic through an indwelling interscalene catheter, and could thus avoid the need for placement of a catheter. Current existing data, although inconclusive, has in some studies shown an equal analgesic effect as catheters. As per pharmacy, the cost of the On-Q pump and the local anesthesia needed for the pump together cost $390 for each indwelling catheter placed, not including the cost of anesthesia and pharmacy supplies and labor. The cost of each 20 mL vial of Exparel is less at $285 and, for a single shot nerve block, would avoid the extra costs and time needed for a catheter placement.

The investigators would like to perform a prospective randomized controlled pilot study to examine the efficacy of single shot interscalene blocks using Exparel versus the traditional interscalene catheter used at our institution. The purpose of the study the investigators are proposing is to determine if single shot interscalene nerve blocks using Exparel can provide equivalent or better analgesia than indwelling interscalene catheter in patients who undergo total shoulder replacement surgery. If so, single shot interscalene nerve blocks with Exparel may serve as a quicker, easier, cheaper, safer, and more comfortable alternative to placing indwelling interscalene catheters.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

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
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

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

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesia (ASA) 1, 2, and 3
  • Ages 40-74
  • Patients scheduled for total shoulder replacement

Exclusion Criteria:

  • ASA 4 and 5
  • Pre-existing pain disorder
  • Regular consumption of chronic pain medication
  • pregnant women
  • any medical condition such as a clotting disorder
  • anatomic abnormality that precludes use of an indwelling scalene catheter
  • Body Mass Index (BMI) >40
  • Patient refusal
  • Pre-existing diabetic neuropathy or Hemoglobin A1c >9
  • Failed block

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single shot Interscalene Nerve Block
This group will receive an interscalene nerve block. This will be administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.
Drug: Exparel
A shot of long acting local anesthetic for post operative pain management
Other Names:
  • liposomal bupivacaine
Active Comparator: Indwelling Interscalene Catheter
This group will receive an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The "On-Q" pump will be set at a rate of 4 mL/hr.
Device: Indwelling Interscalene Catheter
ropivacaine, given through a catheter inserted between the shoulders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Requirements Assessed at 24 Hours Post-surgery
Time Frame: 24 Hours post-surgery
Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.
24 Hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-Operative Opioid Requirements
Time Frame: Duration of Surgery (Approximately 3 hours)
Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.
Duration of Surgery (Approximately 3 hours)
Pain Score in Post Anesthesia Care Unit (PACU)
Time Frame: During time in PACU (up to 5 hours)
Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)
During time in PACU (up to 5 hours)
Opioid Requirements Assessed at 8-hours Post-surgery
Time Frame: 8 hour post-surgery
8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.
8 hour post-surgery
Opioid Requirements Assessed at 48 Hours Post-surgery
Time Frame: 48 hours post-surgery
48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.
48 hours post-surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: At Discharge (up to 3 days)
Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.
At Discharge (up to 3 days)

Collaborators and Investigators

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

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Elilary Montilla Medrano, MD, Montefiore Medical Center

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)

January 22, 2019

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-9707

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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