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临床试验/NCT02321787
NCT02321787已完成不适用

Utility of Ultrasonography for Confirmation of Successful Caudal Epidural Injection

Ann & Robert H Lurie Children's Hospital of Chicago2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Rate of block success in traditional group versus intervention (ultrasound) group

研究概览

简要总结

The purpose of our study is to evaluate whether utilizing ultrasound assessment during caudal epidural injection can reliably identify unrecognized and unsuccessful nerve blocks during the procedure, guide proper technique, and alter pain management outcome measurements for patients.

Patients will be randomized to a group either undergoing caudal injection by a trainee using typical techniques or by using typical techniques in addition to ultrasound for confirmation of successful injection. The patients enrolled in this study will have the same intraoperative care, in line with the standard of care. Data will be collected intraoperatively and postoperatively on pain scores, time for performance of caudal block, and perceived success of the block. There will be no direct benefit to the patients enrolled in this study, but future patients may benefit from the use of ultrasound for the confirmation of a successful block.

详细描述

Caudal epidural injection is the most commonly performed regional anesthetic procedure in infants and children and is used to provide perioperative analgesia for many lower abdominal, lower extremity, and urological procedures. Utilizing sterile technique, a needle is advanced through the sacral hiatus and local anesthetic is injected into the epidural space. Local anesthetic spreads cranially and results in significant sensory (+/- motor) blockade, depending on local anesthetic concentration and volume1. Recent studies have used ultrasound to assess cranial spread during caudal blockade, specifically evaluating how speed of injection and different volumes can affect cranial spread2,4. Other studies have investigated redistribution and secondary spread after initial injection of local anesthetic by utilizing ultrasound assessment of the epidural space3.

Although no current standard exists for confirming successful caudal epidural injection, several findings may indicate a proper needle position and can predict successful block5. Some of these findings include: tactile appreciation of the "pop" through the sacrococcygeal ligament, negative blood or cerebrospinal fluid aspiration, negative test dose, appropriate resistance during injection, no subcutaneous swelling during injection, no motor or hemodynamic response to skin incision, and no need for administration of supplemental analgesics. Although several studies have shown that real-time ultrasound guidance can be used during needle insertion for caudal block, this does not guarantee adequate cranial spread and may be technically challenging for a trainee performing the block. Furthermore, many of the tactile findings that indicate successful entry into the appropriate space can only be appreciated by the trainee, not the supervising anesthesiologist, which complicates supervision of this technique. At present, difficulty in reliably predicting block failure may lead to overuse of narcotics to prevent pain in patients with potentially failed blocks or could lead to inadequate analgesia in patients too young to reliably communicate their pain level.

The purpose of our study is to evaluate whether utilizing ultrasound assessment during caudal epidural injection can reliably identify unrecognized and unsuccessful nerve blocks during the procedure, guide proper technique, and alter pain management outcome measurements for patients.

The proposed study will not change the current practice with regard to patient selection for caudal epidural injection and will not change the performance of the procedure itself. This study may impact the practice of general pediatric anesthesiologists by providing evidence that ultrasound is a useful tool for determining successful caudal epidural injection, may help identify unrecognized failed blocks earlier and will evaluate which level(s) of anesthesia training would most benefit from this assessment tool.

Patients will be randomized using pre-made folders containing an assignment to either the control group or study group. In the study group, ultrasound will be utilized in the caudal block to confirm placement. In the control group, the caudal block will be done without ultrasound to assist with caudal epidural injection. In the operating room, once the anesthesia team is prepared to begin the caudal epidural injection, the patient will be placed in the lateral decubitus or prone position, with knees and hips flexed. The attending for the caudal block will mark the site on the patient per the site marking policy at Lurie Children's; this is not necessarily the attending of record for the remainder of the case. Once the sacrum is prepped, the anesthesia provider will proceed with the caudal epidural injection in the usual fashion. The injected solution will be 1 mL/kg of 0.2% ropivacaine with 1:200k epinephrine, rounded up to the next mL, which is consistent with the current standard practice at Lurie Children's. After injection of test dose (10% of the total block volume), a one-minute pause will begin to assess for a response. During this pause, prior to injection of the remaining dose of local anesthetic, a 13-6 MHz, linear ultrasound probe with a sterile covering and ultrasound gel will be placed over the patient's lumbar spine, cranial to the point of entry for the caudal block. The caudal block needle insertion site and sterile field will be observed and undisturbed. The ultrasound probe will be positioned paramedian along the non-dependent side of the spine, obtaining a long axis view of the epidural and intrathecal space. The cephalad end of probe will be placed at the level of the iliac crest. Once the ultrasound probe is positioned properly and the one-minute pause has finished, the remaining dose of local anesthetic will be administered by the anesthesia provider as an ultrasound clip of epidural spread is visualized.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Under the age of eight
  • 20kg or less
  • Who are undergoing lower abdominal, lower extremity orthopedic, or urological procedures in the operating room at Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie Children's) and will have a caudal epidural injection performed by an anesthesia resident physician prior to surgical incision
  • Children will be the sole patient population for this study

排除标准

  • Patients will be excluded if their ultrasound images are deemed inadequate for evaluation of epidural injection
  • The caudal injection is abandoned after unsuccessful attempts
  • The surgical incision is at or above the umbilicus

结局指标

主要结局

Rate of block success in traditional group versus intervention (ultrasound) group

时间窗: 4 hours

Success in the ultrasonographic group will be estimated by ultrasound spread and in the traditional group by heart rate, need for additional medications, and pain scores.

次要结局

  • Opioid Administration(4 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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