Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
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Duke University
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | November 1, 2018 | ||
| 预计主要完成日期 | November 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Postoperative opioid consumption[ Time Frame: 2 hours postoperatively ] Amount of opioid Postoperative opioid consumption[ Time Frame: 6 hours postoperatively ] Amount of opioid Postoperative opioid consumption[ Time Frame: 24 hours postoperatively ] Amount of opioid Postoperative opioid consumption[ Time Frame: 48 hours postoperatively ] Amount of opioid Postoperative pain scores[ Time Frame: 2 hours postoperatively ] VAS pain scores at rest and with movement 0-10 Postoperative pain scores[ Time Frame: 6 hours postoperatively ] VAS pain scores at rest and with movement 0-10 Postoperative pain scores[ Time Frame: 24 hours postoperatively ] VAS pain scores at rest and with movement 0-10 Postoperative pain scores[ Time Frame: 48 hours postoperatively ] VAS pain scores at rest and with movement 0-10 |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section | ||
| 正式标题 ICMJE | Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section | ||
| 简要概况 | The purpose of this prospective single center, randomized study is to determine if ultrasound guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section. |
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| 详细说明 | The typical anesthetic for cesarean section at Duke University Hospital includes a spinal or combined spinal epidural anesthetic with intrathecal dosing of 1.4-1.6 mL bupivacaine HCl 0.75%, 15 mcg fentanyl, and 150 mcg morphine. If the epidural component of a combined spinal epidural anesthetic is used, the subject will be withdrawn from the study. Patients also receive rectal acetaminophen 975 mg prior to incision; intravenous (IV) ondansetron 4 mg, IV metoclopramide 10 mg, IV famotidine 20 mg and IV dexamethasone 4 mg intraoperatively; and IV ketorolac 15 mg prior to skin closure. There will be no change to this typical practice. Patients who consent to be in this study will be randomized to receive one of three truncal nerve blocks using an online randomization program by the study PI (AK/EG): (1) ultrasound-guided bilateral classic TAP block; (2) ultrasound-guided bilateral anterior QL (also known as transmuscular or QL type 3) block; (3) ultrasound-guided bilateral ESP block at the level of T9. These nerve blocks will be performed after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. Nerve blocks will be performed by a dedicated and trained group of regional anesthesiologists. This non-blinded regional anesthesiologist will save an ultrasound image after local anesthetic administration while the needle is still in position on each side. The study team will review these images to ensure a high quality of block performance. Patients will have standard postoperative pain medication orders, including acetaminophen 975 mg PO Q6H for 4 days (scheduled, starting 6 hours after intraoperative rectal dose), ketorolac 15 mg IV Q6H for 24 hours (scheduled, starting 6 hours after intraoperative dose), ibuprofen 600 mg PO Q6H for 3 days (scheduled, starting 24 hours after first dose of ketorolac) and oxycodone 5-10mg PO Q3-4H PRN for 4 days. If patients are unable to tolerate oral medication or oxycodone is insufficient, rescue medications may be ordered: IV morphine 1-2 mg or IV hydromorphone 0.3-0.5 mg Q4H as needed. There is no change from the standard postoperative order sets used for patients after cesarean section. Subjects' verbal pain scores at rest and with movement as well as opioid consumption will be recorded at 2, 6, 24, and 48 hours postoperatively. Additionally, the amount of antiemetics and antipruritics used will also be recorded at the above time points. These scores will be entered into a Duke University Hospital REDCap database. Subjects will also be sent a survey assessing their satisfaction with pain control one week after discharge via email or telephone. This information will be collected via Duke University Hospital REDCap. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 4 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Patients will be randomly assigned to one of three treatment groups, TAP, QL, or ESP blocks 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
75 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 1, 2019 | ||
| 预计主要完成日期 | November 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) Physical Status 1-3 2. Age greater than or equal to 18 years 3. Scheduled for elective cesarean section 4. English speaking Exclusion Criteria: 1. ASA Physical Status 4-5 2. Diagnosis of chronic pain 3. Chronic opioid use (opioid use in the past 3 months) 4. Preoperative use of SSRIs (Celexa, Lexapro, Prozac, Paxil), SNRIs (Cymbalta, Effexor), gabapentin, or pregabalin (Lyrica) 5. Inability to cooperate with or understand protocol 6. Inability to communicate pain scores or need for analgesia 7. Infection at the site of block placement 8. Intolerance or allergy to local anesthetics 9. Neurologic deficit or disorder 10. Blood thinning disorder or taking anticoagulant medication 11. BMI > 50 kg/m2 12. Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years 13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance 14. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Duke University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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