EUCTR2016-001656-22-BE进行中（未招募）1 期
The utility of liposomal bupivacaine for anesthesia and analgesia in patients treated with collagenase for the release of Dupuytren’s contracture: A randomized controlled trial.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female, at least 18 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; or at least 2 years postmenopausal or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Currently pregnant, nursing or planning to become pregnant during the study or within 1 moth after study drug administration
- •Planned concurrent surgical procedure
- •Previous Dupuytren’s contracture on the hand being considered for surgery
- •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 to of peripheral nerves or to communicate with staff
- •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 <50 kg (110 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
- •Malignancy in the last 2 years, with exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
- •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
研究者
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