Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery
报名条件（概要）
- 年龄：18 Years – 65 Years
- 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
China
药品与企业信息
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.5ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare diprospan at concentrations of 0.012%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.375ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare diprospan at concentrations of 0.009%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.25ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare diprospan at concentrations of 0.006%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.125ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare diprospan at concentrations of 0.003%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 15 ml of ropivacaine will be diluted to 30 ml with in 0.9% NaCl, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.
研发企业
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）
Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.
适应症
主动联系研究团队
中国／港澳台研究中心
- Beijing Tiantan HospitalBeijing，Beijing Municipality，China
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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: Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery ClinicalTrials.gov Identifier: NCT06785350 Sponsor: Beijing Tiantan Hospital Investigational product: 0.012%diprospan+0.5%ropivacaine, 0.009%diprospan+0.5%ropivacaine, 0.006%diprospan+0.5ropivacaine, 0.003%diprospan+0.5%ropivacaine, 0.5%ropivacaine 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：Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery 试验编号：NCT06785350 申办方：Beijing Tiantan Hospital 研究药物：0.012%diprospan+0.5%ropivacaine、0.009%diprospan+0.5%ropivacaine、0.006%diprospan+0.5ropivacaine、0.003%diprospan+0.5%ropivacaine、0.5%ropivacaine 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）
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？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 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）。