Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants Who Completed a Successful Intervention With No Major Adverse Events
研究概览
简要总结
Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort of children undergoing surgical sternotomy prior to planning an appropriately powered, randomized, controlled trial of the same.
Hypothesis: The investigators' primary hypothesis is that utilizing bilateral erector spinae blocks for post-sternotomy pain is a feasible intervention for consideration in a larger trial by demonstrating a 75% or greater successful intervention completion rate without any major adverse outcomes.
详细描述
Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving subfield of anesthesia practice driven with considerable urgency by the growing recognition that even appropriate perioperative narcotic administration can have significant derogatory long-term effects.
Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with minimal additional patient risk and as such have become routine components of opioid-sparing intraoperative and postoperative pain management plans for surgical patients at BCH. In addition to the postulated benefit of reducing overall opioid exposure and potentially reducing the risk for long term physiologic and behavioral dependence upon opioids, regional anesthetics may allow for earlier extubation after selected surgeries, shorter ICU, PACU and inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and improved patient satisfaction scores.
Despite a robust literature supporting the safety and efficacy of regional anesthesia for postoperative pain control across a broad range or surgery types, patient demographics and underlying comorbidities, there are certain classes of surgeries that have (to date) not benefitted from the advantages that regional anesthetics may provide, most notably spine surgery and cardiac surgery.
Concerns have been expressed with regard to regional anesthetics for cardiac surgeries in particular (this being the primary surgical type associated with sternotomies in a pediatric populations), given that most patients are pharmacologically anticoagulated to some extent during their procedures and are thus at increased risk for bleeding. This is further complicated in the pediatric cardiac surgical population as many of these children are intubated for an extended period of time and therefore may not have particularly reliable neurological exams in the setting of neuraxial regional anesthetics-potentially resulting in unrecognized acquired neurological defecits. While there is emerging evidence of improved outcomes with neuraxial regional anesthetics in adult cardiac surgery patients, this has not trickled down to the pediatric population, likely for some of these reasons.
The investigators at BCH are fortunate to have one of the largest concentrated pediatric cardiac surgical populations in the US along with an active, and well organized regional anesthesia service. Because of this, the investigators are in a unique position to more thoroughly evaluate the effectiveness and safety of regional anesthetics in children following cardiac surgery. Furthermore it is thought to be critical that institutions such as BCH take a leading role in documenting the effects of regional anesthesia on the most important outcome measures when considering perioperative medicine. These include: overall pain management, surgical healing, functional recovery, long term pain symptoms, and emotional/behavioral outcomes after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled as part of the cardiac surgical ERAS program.
- •Scheduled for a primary sternotomy.
- •Ages 3-21 years.
排除标准
- •Patients undergoing reoperative procedures.
- •Significant scoliosis or other anatomic contraindications to ESB.
- •History of bleeding or current therapeutic dose anticoagulant use.
- •Significant intraoperative hemodynamic instability or bleeding, as ascertained by clinicians taking care of the patient.
- •Patients with severe neurodevelopmental delays.
- •Patients with previous chronic pain syndromes.
- •Patients with a history of opioid treatment at any point in the 2 months prior to surgery.
- •Lack of parental consent and/or child assent.
研究组 & 干预措施
Bilateral erector spinae blocks
Bilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Number of Participants Who Completed a Successful Intervention With No Major Adverse Events
时间窗: 48 hours
For this study, 'feasibility' will be defined primarily as a successful intervention completion rate of 75% or greater of all subjects with no major adverse outcomes.
次要结局
- Number of Participants Who Completed a Successful Intervention With a Full Data Set(48 hours)
研究者
Roland Brusseau
SeniorAssociate in Perioperative Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine Instructor in Anaesthesia, Harvard Medical School
Boston Children's Hospital
