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正在招募不适用编号 NCT06845215

Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Postoperative Analgesia Management After Abdominoplasty

报名条件(概要)

  • 年龄:不限 – 不限
  • 性别:不限
  • 健康志愿者:接受

完整入排标准请以官方页面为准。

开展国家/地区

Turkey (Türkiye)

药品与企业信息

Transversus abdominis plane (TAP) block治疗操作

Ultrasound-guided TAP block

Erector spina plane block (ESP)治疗操作

Ultrasound-guided ESP block

研发企业

Ankara Ataturk Sanatorium Training and Research HospitalOTHER_GOV

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。

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)

Introduction: Abdominoplasty involves the removal of excess skin and fat from the abdominal region, rectus sheath plication, and umbilical transposition. The number of cosmetic abdominoplasty procedures has been steadily increasing in recent years. Due to extensive tissue manipulation and large incisions during surgery, postoperative pain has become a significant concern. Studies report that up to 80% of patients experience postoperative pain; however, fewer than half of these patients receive adequate analgesia. Improving postoperative pain control has been shown to facilitate early mobilization, reduce hospital length of stay, lower healthcare costs, and enhance patient satisfaction. Therefore, ensuring effective postoperative analgesia has become a critical aspect of patient management. Transversus abdominis plane (TAP) block and erector spinae plane (ESP) block are peripheral nerve block techniques that can be used as part of a multimodal analgesia approach for postoperative pain management after abdominoplasty. In this study, we aimed to compare the effects of TAP and ESP blocks on postoperative pain in patients undergoing abdominoplasty. Aim/Hypothesis: H0: There is a significant difference in the analgesic efficacy between ultrasound-guided ESP and TAP blocks in postoperative pain management after abdominoplasty. H1: There is not a significant difference in the analgesic efficacy between ultrasound-guided ESP and TAP blocks in postoperative pain management after abdominoplasty. Materials and Methods: Our study was designed as a retrospective analysis. Patient records and hospital database will be reviewed to identify all patients who underwent abdominoplasty and received TAP block or ESP block for postoperative analgesia. Demographic data including age, gender, weight, height, body mass index (BMI) and American Society of Anesthesiologists (ASA) classification, as well as comorbidities and medications used will be recorded on case report forms. The type of block performed (TAP or ESP) and postoperative pain scores obtained from pain assessment forms using the Numerical Rating Scale (NRS) at 0, 2, 4, 6, 12 and 24 hours postoperatively will be documented. In addition, data from the patient-controlled analgesia (PCA) device will be recorded, including number of doses demanded (DEM) and number of doses delivered (DEL). Other parameters such as additional analgesic requirements, postoperative nausea and vomiting, itching and patient satisfaction will also be recorded.

适应症

AbdominoplastyPostoperative PainTransversus Abdominis Plane (TAP) BlockErector Spinae Plane Block

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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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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: Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Postoperative Analgesia Management After Abdominoplasty
ClinicalTrials.gov Identifier: NCT06845215
Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Investigational product: Transversus abdominis plane (TAP) block, Erector spina plane block (ESP)

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:Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in Postoperative Analgesia Management After Abdominoplasty
试验编号:NCT06845215
申办方:Ankara Ataturk Sanatorium Training and Research Hospital
研究药物:Transversus abdominis plane (TAP) block、Erector spina plane block (ESP)

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 drerbilturksal@hotmail.com

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