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正在招募不适用编号 NCT06857110

"Supracondylar Radial Nerve Block Guided by Ultrasound Versus Hematoma Block for Analgesic Management in Closed Reduction of Distal Radius Fractures"

报名条件(概要)

  • 年龄:18 Years – 不限
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

Colombia

药品与企业信息

ultrasound-guided supracondylar block of the radial nerve治疗操作

75 mg of intramuscular diclofenac will be administered, or 1 gram of oral acetaminophen in case of contraindications for the administration of Non-Steroidal Anti-inflammatory Drugs

hematoma block治疗操作

The orthopedic surgeon will perform a hematoma block before closed reduction. Intramuscular diclofenac (75 mg) or oral acetaminophen (1 g) will be administered if NSAIDs are contraindicated. With the patient in a supine position, the fracture site will be identified through palpation. After antisepsis with 2% chlorhexidine gluconate, a 10 cc syringe with a 21-gauge needle will be inserted to aspirate and confirm placement over the fracture hematoma. Then, 1% lidocaine (2 mg/kg) without epinephrine will be infiltrated. A 10-minute waiting period will be observed before performing closed reduction maneuvers.

5 mg of intramuscular diclofenac药物

the orthopedic surgeon on duty will perform the hematoma block prior to closed reduction in the procedure room as follows: 75 mg of intramuscular diclofenac will be administered

研发企业

Hospital Universitario San Ignacio研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • Pontificia Universidad Javeriana研究机构/其他

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

Non-surgical treatment with closed reduction and immobilization using a splint or cast is the preferred approach for stable distal radius fractures, particularly in elderly patients. It is also the initial intervention for displaced fractures with a surgical indication before the procedure, aiming to reduce edema, manage pain, and prevent associated complications. However, the maneuvers required for bone reduction can cause significant pain, and there is still insufficient evidence to favor one anesthetic method over another. In recent years, there has been a trend toward utilizing local methods, such as hematoma block or ultrasound-guided supracondylar block of the radial nerve, due to their lower incidence of complications. Nonetheless, there are currently no studies comparing the efficacy of these two analgesic approaches. This study aims to compare the analgesic effect of ultrasound-guided supracondylar block with that obtained through hematoma block in patients with distal radius fracture during closed reduction, using the Numeric Rating Scale. Additionally, it aims to compare the quality of the reduction through radiographic measures and assess the frequency of adverse events after the two interventions.

适应症

Distal Radius Fracture

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

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研究中心联系方式

问自己是否符合条件、如何预筛

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: "Supracondylar Radial Nerve Block Guided by Ultrasound Versus Hematoma Block for Analgesic Management in Closed Reduction of Distal Radius Fractures"
ClinicalTrials.gov Identifier: NCT06857110
Sponsor: Hospital Universitario San Ignacio
Investigational product: ultrasound-guided supracondylar block of the radial nerve, hematoma block, 5 mg of intramuscular diclofenac

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:"Supracondylar Radial Nerve Block Guided by Ultrasound Versus Hematoma Block for Analgesic Management in Closed Reduction of Distal Radius Fractures"
试验编号:NCT06857110
申办方:Hospital Universitario San Ignacio
研究药物:ultrasound-guided supracondylar block of the radial nerve、hematoma block、5 mg of intramuscular diclofenac

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 lagarcia@husi.org.co

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面