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Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis (LELIBU)

Primary Purpose

Tennis Elbow, Lateral Epicondylitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Liposomal bupivacaine
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • written informed consent
  • age 18-65
  • employed
  • chronic lateral epicondylitis (duration >3 months)
  • pain in lateral epicondyle
  • pain in resisted wrist extension in elbow extension (Cozen test)
  • X-ray or Magnetic resonance imaging (MRI) of the elbow (<12 months from enrollment) with no pathological findings other than lateral epicondylitis

Exclusion Criteria:

  • pregnancy, verbal confirmation from patient required
  • unemployment
  • allergy to levobupivacaine, bupivacaine or liposomal bupivacaine
  • constant use of strong analgesics (e.g. opioids)
  • other source of elbow pain (e.g. medial epicondylitis, distal biceps/triceps tendinitis)
  • bilateral epicondylitis
  • inability to give informed consent
  • inability to understand the enrollment forms or to fill patient diary (forms are written in Finnish)
  • previous injection treatment (e.g. cortisone, botulin toxin A, autologous plasma) for lateral epicondylitis during the past 3 months
  • severe hepatic disease, or other underlying severe illness (cardiac failure, cancer, other systemic diseases)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Levobupivacaine arm

    Liposomal Bupivacaine arm

    Arm Description

    Patients will receive a single injection of 10 mL of 0.5% (5 mg/mL) levobupivacaine into the common extensor origin.

    Patients will receive a single injection of 10 mL (133mg) of liposomal bupivacaine into the common extensor origin.

    Outcomes

    Primary Outcome Measures

    Pain
    pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome
    Pain
    pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome

    Secondary Outcome Measures

    Pain
    pain during grip reported by patient on Visual Analogue Scale (VAS),
    Pain
    pain during grip reported by patient on Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome
    Disability
    Patient reported outcome measure Disabilities of the Arm, Shoulder and Hand, scale 0-100, higher value indicating worse outcome
    Disability
    Patient reported outcome measure Disabilities of the Arm, Shoulder and Hand, scale 0-100, higher value indicating worse outcome
    Disability
    Patient reported outcome measure Oxford Elbow Score, scale 0-100, lower value indicating worse outcome
    Disability
    Patient reported outcome measure Oxford Elbow Score, scale 0-100, lower value indicating worse outcome
    Disability
    total number of days of work lost due to epicondylalgia
    Disability
    total number of days of work lost due to epicondylalgia
    Pain
    reduction in the amount of each pain medication taken
    Pain
    reduction in the amount of each pain medication taken

    Full Information

    First Posted
    April 28, 2020
    Last Updated
    May 6, 2020
    Sponsor
    Turku University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04382144
    Brief Title
    Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis
    Acronym
    LELIBU
    Official Title
    Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis - Off-Label, Investigator Initiated Randomized, Controlled, Double-Blind Cross-Over Treatment Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Turku University Hospital

    4. Oversight

    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

    5. Study Description

    Brief Summary
    The main objective of the trial is to compare the effectiveness of injected levobupivacaine and liposomal bupivacaine in the treatment of pain and disability in patients with lateral epicondylitis. Primary outcome is pain (VAS) at 1 week and at 1 month after injection. Secondary outcomes are the Quick Disabilities of the Arm, Shoulder and Hand DASH (Quick DASH) and Oxford Elbow Score (OES) and a record of time off work due to lateral epicondylitis in days at 1 week and at 1 month. The study will be a cross-over trial
    Detailed Description
    This project compares bupivacaine and long acting liposomal bupivacaine in the treatment of pain and disability related to lateral epicondylitis. The investigational medicinal products will be Chirocaine, ABBVIE OY, Espoo, Finland (levobupivacaine) and Exparel®, Pacira Pharmaceuticals, Inc., Parsippany, N.J. (liposomal bupivacaine). The design of the study will be an off-label, investigator initiated, randomized, controlled, double-Blind cross over treatment trial. Exparel (liposomal bupivacaine) will be the medicinal product in the intervention arm, whilst Chirocaine (levobupivacaine) will serve as the active control. Patients for the study will be recruited from the patients referred to the hand surgery outpatient clinic at Turku University Hospital, Finland. During the pilot phase of the study, four patients will be recruited, after which power analysis is done. The main study will include up to 50 patients, 25 patients in each study arm. Patient enrollment will start immediately after the all the relevant permits have been obtained (estimated September 2020). Normal distribution of data will be tested by Shapiro-Wilks test. The mean and Standard Deviation will be reported for normally distributed data. For data not distributed normally, the median and inter quartile ranges of the data will be reported. Independent samples t-test will be used for between-group comparison (normal distribution). The Mann-Whitney test will be used for non-normal data. The results will be published in a peer reviewed international academic journal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tennis Elbow, Lateral Epicondylitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Model Description
    The trial will be a crossover study. During the pilot phase, we will recruit up to 6 patients, after which we will do a power analysis. In the main study, up to 25 patients will be randomized into 2 groups. Group 1 will receive an injection af levobupivacaine (Chirocaine) into the lateral epicondylitis. The outcomes are assessed over the next month and then they are given the injection of liposomal bupivacaine (Exparel). Normal distribution of data will be tested by Shapiro-Wilks test. The mean and Standard Deviation will be reported for normally distributed data. For data not distributed normally, the median and inter quartile ranges of the data will be reported. Independent samples t-test will be used for between-group comparison (normal distribution). The Mann-Whitney test will be used for non-normal data.
    Masking
    Care Provider
    Masking Description
    A nurse at the outpatient clinic will choose an envelope with the randomization information and assign the patient into their groups. The same nurse will prepare the injection, mask the syringe with a tape and give it to the doctor who will administer the injection. The same injection technique will be used for both drugs.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Levobupivacaine arm
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive a single injection of 10 mL of 0.5% (5 mg/mL) levobupivacaine into the common extensor origin.
    Arm Title
    Liposomal Bupivacaine arm
    Arm Type
    Experimental
    Arm Description
    Patients will receive a single injection of 10 mL (133mg) of liposomal bupivacaine into the common extensor origin.
    Intervention Type
    Drug
    Intervention Name(s)
    Liposomal bupivacaine
    Intervention Description
    Patient will receive a single injection of a local anesthetic into the common extensor origin.
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome
    Time Frame
    1 week
    Title
    Pain
    Description
    pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Pain
    Description
    pain during grip reported by patient on Visual Analogue Scale (VAS),
    Time Frame
    1 week
    Title
    Pain
    Description
    pain during grip reported by patient on Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome
    Time Frame
    1 month
    Title
    Disability
    Description
    Patient reported outcome measure Disabilities of the Arm, Shoulder and Hand, scale 0-100, higher value indicating worse outcome
    Time Frame
    1 week
    Title
    Disability
    Description
    Patient reported outcome measure Disabilities of the Arm, Shoulder and Hand, scale 0-100, higher value indicating worse outcome
    Time Frame
    1 month
    Title
    Disability
    Description
    Patient reported outcome measure Oxford Elbow Score, scale 0-100, lower value indicating worse outcome
    Time Frame
    1 week
    Title
    Disability
    Description
    Patient reported outcome measure Oxford Elbow Score, scale 0-100, lower value indicating worse outcome
    Time Frame
    1 month
    Title
    Disability
    Description
    total number of days of work lost due to epicondylalgia
    Time Frame
    1 week
    Title
    Disability
    Description
    total number of days of work lost due to epicondylalgia
    Time Frame
    1 month
    Title
    Pain
    Description
    reduction in the amount of each pain medication taken
    Time Frame
    1 week
    Title
    Pain
    Description
    reduction in the amount of each pain medication taken
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: written informed consent age 18-65 employed chronic lateral epicondylitis (duration >3 months) pain in lateral epicondyle pain in resisted wrist extension in elbow extension (Cozen test) X-ray or Magnetic resonance imaging (MRI) of the elbow (<12 months from enrollment) with no pathological findings other than lateral epicondylitis Exclusion Criteria: pregnancy, verbal confirmation from patient required unemployment allergy to levobupivacaine, bupivacaine or liposomal bupivacaine constant use of strong analgesics (e.g. opioids) other source of elbow pain (e.g. medial epicondylitis, distal biceps/triceps tendinitis) bilateral epicondylitis inability to give informed consent inability to understand the enrollment forms or to fill patient diary (forms are written in Finnish) previous injection treatment (e.g. cortisone, botulin toxin A, autologous plasma) for lateral epicondylitis during the past 3 months severe hepatic disease, or other underlying severe illness (cardiac failure, cancer, other systemic diseases)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joona Ikonen, MD
    Phone
    +358 (0)2 3130298
    Email
    joona.ikonen@tyks.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Markus Pääkkönen, PhD, Docent
    Phone
    +358 (0)2 313 0000
    Email
    markus.paakkonen@tyks.fi
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Markus Pääkkönen, PhD, Docent
    Organizational Affiliation
    Turku University Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis

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