Status:
UNKNOWN
Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis
Lead Sponsor:
Turku University Hospital
Conditions:
Tennis Elbow
Lateral Epicondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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. P...
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 Chiroc...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04382144
Start Date
September 1 2020
End Date
May 1 2022
Last Update
May 11 2020
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