Clinical trial: Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis (NCT04382144)

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)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 17-year-old male comes to the office due to several months of right elbow pain.  The pain is worse with activity and limits his workouts and activities.  He has tried over-the-counter medications with limited relief.  Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment.  He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy.

Patient description (patient's own words): I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already.

Does the patient match the trial criteria? Contradiction