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
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 主要终点
- Pain
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •age 18-65
- •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
排除标准
- •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)
研究组 & 干预措施
Levobupivacaine arm
Patients will receive a single injection of 10 mL of 0.5% (5 mg/mL) levobupivacaine into the common extensor origin.
干预措施: Liposomal bupivacaine (Drug)
Liposomal Bupivacaine arm
Patients will receive a single injection of 10 mL (133mg) of liposomal bupivacaine into the common extensor origin.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Pain
时间窗: 1 month
pain at rest reported by patient on a Visual Analogue Scale (VAS), scale 0-100, higher value indicating worse outcome
次要结局
- Pain(1 month)
- Disability(1 month)
研究者
Markus Paakkonen
Head of Department, Hand Surgery
Turku University Hospital