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Exparel Interscalene vs Indwelling Catheter

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ClinicalTrials.gov Identifier: NCT03827213
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Elilary Montilla Medrano, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE January 22, 2019
Estimated Primary Completion Date September 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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.
  • 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.
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Exparel Interscalene vs Indwelling Catheter
Official Title  ICMJE Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Exparel
    A shot of long acting local anesthetic for post operative pain management
    Other Name: liposomal bupivacaine
  • Device: Indwelling Catheter
    ropivacaine, given through a catheter inserted between the shoulders
Study Arms  ICMJE
  • Experimental: Exparel
    an injection of the drug Exparel, a form of the anesthetic bupivacaine
    Intervention: Drug: Exparel
  • Active Comparator: Indwelling Catheter
    ropivacaine, given through a catheter inserted between the shoulders
    Intervention: Device: Indwelling Catheter
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 29, 2020
Estimated Primary Completion Date September 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elilary Montilla Medrano, MD (718) 920-4316 Emontill@montefiore.org
Contact: Singh Nair, PhD 71892075932 sinair@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827213
Other Study ID Numbers  ICMJE 2018-9707
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elilary Montilla Medrano, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elilary Montilla Medrano, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP