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

• Status: Not yet recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Treatments: Bupivacaine

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)