Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis
NCT04382144 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2020-05-11
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
Conditions
- Tennis Elbow
- Lateral Epicondylitis
Interventions
- DRUG
-
Liposomal bupivacaine
Patient will receive a single injection of a local anesthetic into the common extensor origin.
Sponsors & Collaborators
-
Turku University Hospital
lead OTHER_GOV
Principal Investigators
-
Markus Pääkkönen, PhD, Docent · Turku University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-01
- Primary Completion
- 2021-12-31
- Completion
- 2022-05-01
- FDA Drug
- Yes
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