Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery
报名条件（概要）
- 年龄：30 Years – 60 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
Pakistan
药品与企业信息
其他名称：Sifi-B
The S-FICB will be given as follows: With the patient in the proper position, the skin will be disinfected and the transducer positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. The transducer will be moved laterally until the sartorius muscle is identified. The needle entry point will be anaesthetized with 2 ml 1% lidocaine and 23G spinal needle will be inserted. After negative aspiration, 1-2 mL of Inj Bupivacain 0.125% will be injected to confirm the proper injection plane between the fascia and the ilio-psoas muscle. A proper injection will result in the separation of the fascia iliaca by the local anesthetic in the medial-lateral direction from the point of injection as described. After the spread of the drug will be seen, the rest of the drug volume will be injected.
其他名称：Iifi-B
The I-FICB will be given in similar manner. In ultrasound guided I-FICB technique, a high frequency linear probe will be placed transversely at the level of the inguinal crease. After the femoral artery is identified, the probe will be moved laterally, and the hypoechoic iliopsoas muscle will be identified which is covered by the hyperechoic fascia iliaca. This fascia invests the femoral nerve medially and laterally covers the sartorius muscle. A needle will be inserted in-plane from lateral to medial and pierces the fascia iliaca at the junction of medial border of sartorius and iliopsoas muscle. Then Inj Bupivacain 0.125% will be deposited deep to fascia iliaca and will be seen spreading toward the femoral nerve medially.
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）
Severe pain associated with thigh and knee fractures makes the positioning for regional anesthesia a challenge. Different modalities to make patient pain free for spinal positioning, post op analgesia and patient satisfaction including supra-inguinal fascia iliaca block (S-FIB) and infra-inguinal fascia iliaca blocks (I-FIB) have been studies. The aim of this study is to compare two blocks in patients undergoing thigh and knee surgeries. A randomized controlled trial study design will be used and 60 patients fulfilling the inclusion criteria will be included. The patients will be divided into 2 groups by simple random sampling. Group A (S-FIB) (n = 30, those who will receive 30 ml of 0.125% bupivacaine) and Group B (I-FIB) (n = 30, those who will receive 30 ml of 0.125% bupivacaine). Depending on the allotted group, patients will be given the block under the guidance of ultrasound in the preoperative area. After block patients will be assessed for ease of spinal positioning using EOSP Scale, postoperative duration of analgesia and patient satisfaction using Likert Scale and data will be recorded on prescribed proforma. All the findings will be noted in a specially designed proforma by the researcher. All the data collected will be entered and analyzed. Quantitative variables will be presented with mean ± SD. Independent sample t-test for duration of postoperative analgesia. Qualitative variables such as ease of spinal positioning and gender will be presented with Chi-Square. A p-value equal to or less than 0.05 will be considered significant.
适应症
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。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Dr Humaira Shahzadi, MBBShumairaali2323@gmail.com00923044128425
- Dr Muhammad Shahid, FCPSshahidnishtar@gmail.com00923336173056
研究中心联系方式
- Sahiwal Medical College SahwalSāhīwāl，Punjab Province，Pakistan
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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 Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery ClinicalTrials.gov Identifier: NCT07221682 Sponsor: Sahiwal medical college sahiwal Investigational product: USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK, USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK 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 Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery 试验编号：NCT07221682 申办方：Sahiwal medical college sahiwal 研究药物：USG GUIDED SUPRA-INGUINAL FASCIA ILIACA BLOCK、USG GUIDED INFRA-INGUINAL FASCIA ILIACA BLOCK 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）
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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）。