NCT03106545已完成2 期
Ultrasound-guided Specific Blocks of the Distal Tibial and Deep Peroneal Nerves at the Level of the Ankle With a Mixture of Bupivacaine + Liposome Bupivacaine v Bupivacaine Alone v General Anesthesia
Catherine Vandepitte, M.D.1 个研究点 分布在 1 个国家目标入组 40 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
- 40
- 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
Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid consumption as compared to bupivacaine alone or to general anesthesia.
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 65 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 65 years of age at screening
- •Scheduled to undergo primary Scarf osteotomy for elective hallux valgus
- •American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- •Female subject must be surgically sterile or have a monogamous partner who is surgically sterile; or be 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 demonstrate sensory function by exhibiting sensitivity to cold, pinprick, and light touch
- •Able to understand the English or Dutch language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- •Able to 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 month after study drug administration
- •Planned concurrent surgical procedure (e.g., bilateral hallux valgus repair)
- •Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to hallux valgus and which may confound the postsurgical assessments (e.g., significant pain from other joints including chronic neuropathic pain, concurrent or prior contralateral knee or foot surgery)
- •Previous hallux valgus on the foot being considered for surgery
- •History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
- •Contraindication to bupivacaine, oxycodone, morphine, or hydromorphone
- •Chronic daily use of long-acting opioid medication or NSAIDs (except for low-dose aspirin used for cardioprotection) within 24 hours
- •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®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to study drug administration.
- •Current use of systemic glucocorticosteroids within 1 month of study enrollment
- •Use of dexmedetomidine HCl (Precedex®) within 3 days of study drug administration
- •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
- •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
- •Suspected or known history of drug or alcohol abuse within the previous year
- •Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
- •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
Single mixture LB & bupivacaine
Experimental
A single mixture of liposome bupivacaine 1.3% (5 mL) + bupivacaine 0.5% (2.5 mL) injected into the distal tibial and deep peroneal nerves
干预措施: Liposome bupivacaine (Drug)
Bupivacaine alone
Active Comparator
Bupivacaine 0.5% (7.5 mL) injected into the distal tibial and deep peroneal nerves
干预措施: Liposome bupivacaine (Drug)
General anesthesia
Sham Comparator
General anesthesia
干预措施: Liposome 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
Change in worst pain over the first postoperative week
时间窗: From discharge from PACU through first postoperative week
Modified BRIEF Pain Inventory (Q1)
次要结局
- Change in ability to use foot(From discharge from PACU through first postoperative week)
- Opioid consumption(From hospital discharge through first postoperative week)
- Change in sleep quality(From discharge from PACU through first postoperative week)
- Change in satisfaction with pain control(From discharge from PACU through first postoperative week)
- Change in sensory response in skin dermatomes(From premedication through first postoperative week)
- Change in motor response in foot(From premedication 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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