NCT03106519已完成2 期
Distal Extremity (Wrist) Nerve Blocks With a Mixture of Liposome Bupivacaine + Bupivacaine Versus Bupivacaine Alone for Patients Having Dupuytren's Contracture Release: a Blinded Randomized Controlled Trial
Catherine Vandepitte, M.D.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年1月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in current pain over the first postoperative week
研究概览
简要总结
Treatment of Dupuytren's contracture requires multiple injections into the palm of the hand to weaken the cords, followed by rupture of the strands 2 days later. Anesthesia is required for both phases of treatment. It is hypothesized that extended-release liposome bupivacaine prolongs nerve blockade of the wrist allowing patients to undergo this 2-part regimen with less pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 18 years and max 85 years of age at screening
- •Scheduled to undergo Dupuytren's contracture release
- •American Society of Anesthesiologists (ASA) physical status I, II or III
- •Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick and light touch
- •Female subjects must be surgically sterile or have a monogamous partner who is surgically sterile; at least 2 years postmenopausal; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study
- •Able to understand the English or Dutch language, purpose and risks of the study
- •Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule and complete all study assessments
排除标准
- •Currently pregnant, nursing or planning to become pregnant during the study or within 1 moth after study drug administration
- •History of hypersensitivity to local anesthetics
- •Contraindication to bupivacaine, paracetamol, ketorolac, oxycodone or morphine
- •Medical condition that will make it difficult to assess sensory distributions of peripheral nerves or to communicate with staff
- •Chronic scheduled use of any of the following medications within the times specified before surgery: long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication within 24 hours
- •Suspected or known recent history (< 3 months) of drug or alcohol abuse
- •Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Dupuytren's contracture and which may confound the postsurgical assessments
- •Infection at the planned block site
- •Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
- •Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration
- •Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
- •Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- •Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity
- •Any chronic condition or disease that would compromise neurological or vascular assessments
- •Presence of preexisting coagulation disorders
- •Baseline neurological deficits
- •History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, coagulopathy or loss of sensation in the extremities
- •Impaired kidney function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L] or blood urea nitrogen level >50 mg/dL [17.9 mmol/L]) or impaired liver function (e.g., serum aspartate aminotransferase [AST] level >3 times the upper limit of normal (ULN) or serum alanine aminotransferase [ALT] level >3 times the ULN
- •Previous participation in an EXPAREL study
- •Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
研究组 & 干预措施
Bupivacaine alone
Active Comparator
Bupivacaine 0.5% (7.5 mL) injected into the median and ulnar nerves
干预措施: Liposome bupivacaine + bupivacaine (Drug)
Single mixture LB & bupivacaine
Experimental
A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the median and ulnar nerves
干预措施: Liposome bupivacaine + bupivacaine (Drug)
结局指标
主要结局
Change in current pain over the first postoperative week
时间窗: From baseline (before nerve block) through first postoperative week
Pain rating (NRS) at rest and with movement
次要结局
- Change in worst pain over the first postoperative week(From discharge from hospital through first postoperative week)
- Change in ability to use hand(From discharge from hospital through first postoperative week)
- Change in sleep quality(From discharge from hospital through first postoperative week)
- Change in satisfaction with pain control(From discharge from hospital through first postoperative week)
- Change in sensory response in skin dermatomes(From beginning of nerve block through first postoperative week)
- Change in motor response in thumb and fingers(From beginning of nerve block through first postoperative week)
研究者
Catherine Vandepitte, M.D.
Director
New York School of Regional Anesthesia
研究点 (1)
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