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

NCT04382144 | Unknown Phase 4 FDA Drug

• 1 other identifier: TYKS/LeLiBu/1-2
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Pain

  pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome

  1 week

• Pain

  pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome

  1 month

Secondary Outcomes (10)

• Pain

  1 week

• Pain

  1 month

• Disability

  1 week

• Disability

  1 month

• Disability

  1 week

Study Arms (2)

Levobupivacaine arm

ACTIVE COMPARATOR

Patients will receive a single injection of 10 mL of 0.5% (5 mg/mL) levobupivacaine into the common extensor origin.

Drug: Liposomal bupivacaine

Liposomal Bupivacaine arm

EXPERIMENTAL

Patients will receive a single injection of 10 mL (133mg) of liposomal bupivacaine into the common extensor origin.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

Patient will receive a single injection of a local anesthetic into the common extensor origin.

Levobupivacaine arm; Liposomal Bupivacaine arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Turku University Hospital: lead

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Markus Pääkkönen, PhD, Docent

  Turku University Hospital

  STUDY DIRECTOR

Central Study Contacts

Joona Ikonen, MD

CONTACT

+358 (0)2 3130298; joona.ikonen@tyks.fi

Markus Pääkkönen, PhD, Docent

CONTACT

+358 (0)2 313 0000; markus.paakkonen@tyks.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: A nurse at the outpatient clinic will choose an envelope with the randomization information and assign the patient into their groups. The same nurse will prepare the injection, mask the syringe with a tape and give it to the doctor who will administer the injection. The same injection technique will be used for both drugs.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department, Hand Surgery

Model Details: The trial will be a crossover study. During the pilot phase, we will recruit up to 6 patients, after which we will do a power analysis. In the main study, up to 25 patients will be randomized into 2 groups. Group 1 will receive an injection af levobupivacaine (Chirocaine) into the lateral epicondylitis. The outcomes are assessed over the next month and then they are given the injection of liposomal bupivacaine (Exparel). 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.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 11, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: May 1, 2022
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share