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
About this trial
This is an interventional treatment trial for Tennis Elbow
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)
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
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
We'll reach out to this number within 24 hrs