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Exparel Interscalene vs Indwelling Catheter

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ClinicalTrials.gov Identifier: NCT03827213
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Roman Margulis, Montefiore Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pain Drug: Exparel Device: Indwelling Catheter Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : April 29, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: Exparel
an injection of the drug Exparel, a form of the anesthetic bupivacaine
Drug: Exparel
A shot of long acting local anesthetic for post operative pain management
Other Name: liposomal bupivacaine

Active Comparator: Indwelling Catheter
ropivacaine, given through a catheter inserted between the shoulders
Device: Indwelling Catheter
ropivacaine, given through a catheter inserted between the shoulders




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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.


Other Outcome Measures:
  1. Length of Stay [ Time Frame: At Discharge (up to 3 days) ]
    collecting how many days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.



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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827213


Contacts
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Contact: Roman Margulis, MD 6465291190 romargul@montefiore.org
Contact: Singh Nair, PhD 71892075932 sinair@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
Contact: Roman Margulis, MD    646-529-1190    romargul@montefiore.org   
Contact: Singh Nair, PhD    718-920-5932    sinair@montefiore.org   
Principal Investigator: Roman Margulis, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Roman Margulis, MD Montefiore Medical Center

Publications:
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Responsible Party: Roman Margulis, Assistant Professor of Anesthesiology, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03827213     History of Changes
Other Study ID Numbers: 2018-9707
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roman Margulis, Montefiore Medical Center:
shoulder surgery, post operative pain

Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents