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

Levobupivacaine versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis – Off-Label, Investigator Initiated Randomized, Controlled, Double-Blind Cross-Over Treatment Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001191-38-FI

Enrollment

Registered

2020-01-07

Start date

2020-03-03

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral epicondylitis

Interventions

Trade Name: Chirocaine 5 mg/ml injektioneste, liuos / infuusiokonsentraatti, liuosta varten Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: LEVOBUPIVACAINE CAS Number: 27262-

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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 ;Timepoint(s) of evaluation of this end point: D0: before injection therapy 1 week 1 month Repeated for the second treatment	—

Measure

Time frame

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 ;Timepoint(s) of evaluation of this end point: D0: before injection therapy 1 week 1 month Repeated for the second treatment

—

Secondary

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

Countries

Finland

Contacts

Public ContactTurku University Hospital

Turku University Hospital

Markus.Paakkonen@tyks.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026