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

Lateral Epicondylitis Clinical Trial

— LELIBU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04382144
• Other study ID #: TYKS/LeLiBu/1-2
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2020
• Source: Turku University Hospital
• Contact: Joona Ikonen, MD
• Phone: +358 (0)2 3130298
• Email: joona.ikonen[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 Chirocaine, ABBVIE OY, Espoo, Finland (levobupivacaine) and Exparel®, Pacira Pharmaceuticals, Inc., Parsippany, N.J. (liposomal bupivacaine).

The design of the study will be an off-label, investigator initiated, randomized, controlled, double-Blind cross over treatment trial. Exparel (liposomal bupivacaine) will be the medicinal product in the intervention arm, whilst Chirocaine (levobupivacaine) will serve as the active control.

Patients for the study will be recruited from the patients referred to the hand surgery outpatient clinic at Turku University Hospital, Finland.

During the pilot phase of the study, four patients will be recruited, after which power analysis is done. The main study will include up to 50 patients, 25 patients in each study arm. Patient enrollment will start immediately after the all the relevant permits have been obtained (estimated September 2020).

Normal distribution of data will be tested by Shapiro-Wilks test. The mean and Standard Deviation will be reported for normally distributed data. For data not distributed normally, the median and inter quartile ranges of the data will be reported. Independent samples t-test will be used for between-group comparison (normal distribution). The Mann-Whitney test will be used for non-normal data.

The results will be published in a peer reviewed international academic journal.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Drug:
• Liposomal bupivacaine
Patient will receive a single injection of a local anesthetic into the common extensor origin.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome	1 week
Primary	Pain	pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome	1 month
Secondary	Pain	pain during grip reported by patient on Visual Analogue Scale (VAS),	1 week
Secondary	Pain	pain during grip reported by patient on Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome	1 month
Secondary	Disability	Patient reported outcome measure Disabilities of the Arm, Shoulder and Hand, scale 0-100, higher value indicating worse outcome	1 week
Secondary	Disability	Patient reported outcome measure Disabilities of the Arm, Shoulder and Hand, scale 0-100, higher value indicating worse outcome	1 month
Secondary	Disability	Patient reported outcome measure Oxford Elbow Score, scale 0-100, lower value indicating worse outcome	1 week
Secondary	Disability	Patient reported outcome measure Oxford Elbow Score, scale 0-100, lower value indicating worse outcome	1 month
Secondary	Disability	total number of days of work lost due to epicondylalgia	1 week
Secondary	Disability	total number of days of work lost due to epicondylalgia	1 month
Secondary	Pain	reduction in the amount of each pain medication taken	1 week
Secondary	Pain	reduction in the amount of each pain medication taken	1 month