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Liposomal Bupivacaine vs Dexamethasone ISB

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047446
Recruitment Status : Suspended (response to COVID-19)
First Posted : August 6, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.

Condition or disease Intervention/treatment Phase
Shoulder Pain Drug: Exparel 133 MG Per 10 ML Injection Drug: Dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : May 27, 2020
Estimated Study Completion Date : May 27, 2020


Arm Intervention/treatment
Experimental: Liposomal bupivacaine & standard bupivacaine Drug: Exparel 133 MG Per 10 ML Injection
10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
Other Name: Liposomal Bupivacaine

Active Comparator: Standard bupivacaine & dexamethasone Drug: Dexamethasone
15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected




Primary Outcome Measures :
  1. Numerical rating scale (NRS) pain at rest over 72 hours [ Time Frame: First 72 hours pain ]
    NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number.


Secondary Outcome Measures :
  1. Numerical rating scale (NRS) pain at rest [ Time Frame: Postanesthesia care unit (0-6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 ]
    NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest.

  2. Numerical rating scale (NRS) pain with movement [ Time Frame: Postanesthesia care unit (0-6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 ]
    NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement

  3. Opioid consumption [ Time Frame: Postanesthesia care unit (0-6 hours postoperative), postoperative day postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 ]
    Opioid consumption, measured in oral morphine equivalents

  4. Patient satisfaction with pain management: scale [ Time Frame: Postanesthesia care unit (0-6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 ]
    Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction

  5. Brief Pain Inventory short-form [ Time Frame: Postanesthesia care unit (0-6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 ]
    The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. It consists of 4 severity items, which, when averaged, can be used as a measure of pain severity. Higher scores indicate more pain.

  6. Duration of analgesic block [ Time Frame: 24, 48, 72, 96 (if needed) hours postoperatively ]
    Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III
  • Age 18 years or older
  • Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion Criteria:

  • History of allergy to local anesthetic, or one of the study medications
  • Pre-existing neurological deficits
  • Psychiatric or cognitive disorders that prohibit patients from following study protocol
  • History of drug or alcohol abuse
  • Chronic opioid use (longer than 3 months)
  • Chronic pain syndromes
  • Infection at the site of injection
  • Patients with severe pulmonary disease
  • Herniated cervical disc, cervical myelopathy
  • Contraindication for general anesthesia and/or interscalene nerve block
  • Pregnancy
  • Open shoulder arthrotomies.
  • Non English speakers

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): NCT04047446


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: David Kim, MD Hospital for Special Surgery, New York
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04047446    
Other Study ID Numbers: 2019-0424
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication
Access Criteria: Researchers who provide a methodologically sound proposal

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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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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents