NCT07644923尚未招募4 期
A Randomized, Single-Blinded, Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study is a prospective randomized trial examining the effect of tranexamic acid (TXA) and aminocaproic acid (ε-Ahx) with local anesthetics and thrombin in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.
All surgical created wounds for any hand surgery will be treated in a randomized fashion with the following four arms:
- Bupivacaine + lidocaine
- Bupivacaine + lidocaine + thrombin
- Bupivacaine + lidocaine + thrombin + tranexamic acid
- Bupivacaine + lidocaine + thrombin + aminocaproic acid
All are applied topically to surgical bed prior to closure of skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Any patient undergoing elective hand surgery
排除标准
- •Any patient with a traumatic or infected open wound (only surgically created wounds will be included)
- •History of chronic pain
- •History of narcotic addiction
- •History of recreational drug dependency
- •History of psychiatric pathology
- •Allergy or hypersensitivity to local anesthetics, recombinant human thrombin or tranexamic acid
- •History of coagulopathy or active thromboembolic disease
- •Any patient receiving a supra/infraclavicular block for anesthesia
- •Pregnancy
- •Hypersensitivity to hamster proteins
- •History of seizures
- •Significant renal impairment (chronic kidney disease stage 3 or greater)
- •History of retinal vascular disease or history of unexplained visual symptoms
- •Active upper urinary tract bleeding
- •History of known hypercoagulable disorder, prior thromboembolic events, or active clotting disorders
- •History of severe hepatic dysfunction (active hepatitis or steatohepatitis, hepatic fibrosis considered cirrhosis)
研究者
研究点 (1)
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