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Liposomal Bupivacaine Versus Bupivacaine for for Postoperative Pain Control in Shoulder Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180943
Recruitment Status : Not yet recruiting
First Posted : November 29, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Linda Demma, MD, PhD, Bassett Healthcare

Brief Summary:
This is a randomized, single blinded clinical trial whose purpose is to assess the impact of liposomal bupivacaine (LB) in a single shot interscalene nerve block compared with standard bupivacaine (same dose) in a single shot interscalene nerve block in terms of postoperative pain control. Specifically, outpatient pain scores,use of postoperative pain medicine and patient-reported functional outcomes after shoulder arthroplasty surgery will be evaluated.

Condition or disease Intervention/treatment Phase
Anesthesia, Local Drug: interscalene nerve block Phase 4

Detailed Description:

Background:

Shoulder arthroplasty is the fastest growing joint replacement surgery in the United States, and optimal postoperative pain management is critical to optimize outcomes for these surgeries. LB has gained popularity for its potential to provide extended postoperative pain relief with possibly fewer side effects. LB (Exparel, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA) has recently gained popularity for its potential to provide extended postoperative pain relief and was recently approved by the FDA for use in interscalene nerve blocks. Several studies have investigated its efficacy after hip and knee arthroplasty and demonstrated efficacy with decreased opioid consumption, early mobilization, lower hospital costs, and shorter length of stay for patients undergoing surgeries such as bunionectomy, open colectomy, umbilical hernia repair, breast augmentation, and total knee arthroplasty. Limited studies have evaluated the efficacy of LB for perioperative pain control in shoulder arthroplasty. Hence, the objective of this study is to determine whether the use of an LB-based multimodal analgesic regimen provides better postoperative pain control and patient satisfaction, greater cost effectiveness, and lower risk profile compared with standard bupivacaine in interscalene nerve bloc

Study Design and Methods:

This will be a prospective, randomized, single blinded, controlled clinical trial comparing patients undergoing shoulder arthroscopy and arthroplasty treated with LB versus standard bupivacaine with a single bolus interscalene block. The block administrator will not be blinded. The patient and the staff members conducting the follow up assessments, phone calls, and data collection will be blinded to treatment assignment. Study drug administrators (anesthesiologists) will not be blinded. There will be at least one unblinded study coordinator who will not be involved in collecting outcome data.

Patients will be randomized in 1:1 ratio to LB or standard bupivacaine with a single bolus interscalene block. Patient will receive the assigned interscalene block preoperatively per usual procedure. The primary outcome, time to first post operative pain medication will be recorded either from the medical record if administered in the hospital or via telephone assessment if consumed outside the hospital. Study staff will contact the patient by phone post op day (POD) 1, 2, and 3 to assess pain levels, pain medication consumption, sleep, and adverse events. The total participation time for each patient will be approximately four days (operative day and POD 1,2,3).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine Versus Bupivacaine for Interscalene Nerve Block for Postoperative Pain Control in Shoulder Arthroplasty/Arthroscopy: a Prospective Randomized Controlled Trial
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: liposomal bupivicaine
interscalene nerve block using liposomal bupivacaine (Exaprel) 10 ml mixed with 0.5% bupivacaine in same syringe - volume of bupivacaine per MD based on pt weight, etc but CANNOT EXCEED 13mL
Drug: interscalene nerve block
intra and post-operative analgesia
Other Name: liposomal bupivicaine

Active Comparator: bupivicaine
interscalene block using standard bupivicaine (combination of ropivacaine 0.5% and lidocaine 2%) (volume per MD based on pt weight) + decadron
Drug: interscalene nerve block
intra and post-operative analgesia
Other Name: liposomal bupivicaine




Primary Outcome Measures :
  1. Time to first post-operative pain medication consumption in minutes from discharge from OR [ Time Frame: 72 hours ]
    time to first post-operative pain medication


Secondary Outcome Measures :
  1. Worst daily post-op pain on a scale 1-10 [ Time Frame: 72 hours ]
    patient reported outcome of pain severity

  2. Least daily post-op pain on a scale 1-10 [ Time Frame: 72 hours ]
    patient reported outcome of pain severity

  3. Average daily post-op pain on a scale 1-10 [ Time Frame: 72 hours ]
    patient reported outcome of pain severity

  4. Total opioid use in morphine equivalents in the first 72 hours post-op [ Time Frame: 72 hours ]
    Total post-op opioid use



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 18 years or older
  • undergoing shoulder arthroscopy or arthroplasty
  • must meet the criteria for standard of care of ambulatory surgery patients per anesthesia guidelines issued by the American Society of Anesthesiologists

Exclusion criteria:

  • contraindications to regional anesthesia,
  • allergy to any component of multimodal analgesia
  • history of opioid use of >50 morphine milligram equivalents (MME) daily,
  • significant peripheral neuropathy or neurologic disorder affecting the upper extremity,
  • cognitive or psychiatric condition that might affect the patient?s assessment or inability to provide informed consent
  • pregnancy (this is an exclusion for surgery as well)

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): NCT04180943


Contacts
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Contact: Jennifer Victory, RN 607-547-6965 jennifer.victory@bassett.org
Contact: Catherine Gilmore, RN 607-547-7926 catherine.gilmore@bassett.org

Locations
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United States, New York
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Contact: Jennifer Victory, RN    607-547-6965    jennifer.victory@bassett.org   
Contact: Catherine Gilmore, RN    607-547-7926    catherine.gilmore@bassett.org   
Principal Investigator: Linda Demma, MD         
Sub-Investigator: Kristen Herbst, MD         
Sponsors and Collaborators
Bassett Healthcare
Investigators
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Principal Investigator: Linda Demma, MD, PhD Bassett Healthcare
  Study Documents (Full-Text)

Documents provided by Linda Demma, MD, PhD, Bassett Healthcare:
Informed Consent Form  [PDF] November 5, 2019

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Responsible Party: Linda Demma, MD, PhD, attending physician - anesthesiology, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT04180943    
Other Study ID Numbers: 1422773
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be available to other researchers outside of the study investigators.

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents