evobupivacaine versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis

Phase 1

• Conditions: ateral epicondylitis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-001191-38-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-07
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

-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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-pregnancy
-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): reduction in pain reported by VAS ;<br> Timepoint(s) of evaluation of this end point: D0: before injection therapy<br> 1 week<br> 1 month<br><br> Repeated for the second treatment<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Oxford Elbow Score (OES)<br> QuickDash<br> time off work due to epicondylagia in days<br> reduction in consumption of pain medication<br> ;<br> Timepoint(s) of evaluation of this end point: D0: before injection therapy<br> 1 week<br> 1 month<br><br> Repeated for the second treatment<br>