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

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ClinicalTrials.gov Identifier: NCT04382144
Recruitment Status : Not yet recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Markus Paakkonen, Turku University Hospital

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


Condition or disease Intervention/treatment Phase
Tennis Elbow Lateral Epicondylitis Drug: Liposomal bupivacaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 1, 2022


Arm Intervention/treatment
Active Comparator: Levobupivacaine arm
Patients will receive a single injection of 10 mL of 0.5% (5 mg/mL) levobupivacaine into the common extensor origin.
Drug: Liposomal bupivacaine
Patient will receive a single injection of a local anesthetic into the common extensor origin.

Experimental: Liposomal Bupivacaine arm
Patients will receive a single injection of 10 mL (133mg) of liposomal bupivacaine into the common extensor origin.
Drug: Liposomal bupivacaine
Patient will receive a single injection of a local anesthetic into the common extensor origin.




Primary Outcome Measures :
  1. Pain [ Time Frame: 1 week ]
    pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome

  2. Pain [ Time Frame: 1 month ]
    pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome


Secondary Outcome Measures :
  1. Pain [ Time Frame: 1 week ]
    pain during grip reported by patient on Visual Analogue Scale (VAS),

  2. Pain [ Time Frame: 1 month ]
    pain during grip reported by patient on Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome

  3. Disability [ Time Frame: 1 week ]
    Patient reported outcome measure Disabilities of the Arm, Shoulder and Hand, scale 0-100, higher value indicating worse outcome

  4. Disability [ Time Frame: 1 month ]
    Patient reported outcome measure Disabilities of the Arm, Shoulder and Hand, scale 0-100, higher value indicating worse outcome

  5. Disability [ Time Frame: 1 week ]
    Patient reported outcome measure Oxford Elbow Score, scale 0-100, lower value indicating worse outcome

  6. Disability [ Time Frame: 1 month ]
    Patient reported outcome measure Oxford Elbow Score, scale 0-100, lower value indicating worse outcome

  7. Disability [ Time Frame: 1 week ]
    total number of days of work lost due to epicondylalgia

  8. Disability [ Time Frame: 1 month ]
    total number of days of work lost due to epicondylalgia

  9. Pain [ Time Frame: 1 week ]
    reduction in the amount of each pain medication taken

  10. Pain [ Time Frame: 1 month ]
    reduction in the amount of each pain medication taken



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT04382144


Contacts
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Contact: Joona Ikonen, MD +358 (0)2 3130298 joona.ikonen@tyks.fi
Contact: Markus Pääkkönen, PhD, Docent +358 (0)2 313 0000 markus.paakkonen@tyks.fi

Sponsors and Collaborators
Turku University Hospital
Investigators
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Study Director: Markus Pääkkönen, PhD, Docent Turku University Hospital
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Responsible Party: Markus Paakkonen, Head of Department, Hand Surgery, Turku University Hospital
ClinicalTrials.gov Identifier: NCT04382144    
Other Study ID Numbers: TYKS/LeLiBu/1-2
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents