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临床试验/NCT02098681
NCT02098681已完成不适用

Society for Pediatric Anesthesia Improvement Network (SPAIN) Chest Wall Deformity Project (Pectus Repair)

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2014年1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
348
试验地点
1
主要终点
Perioperative course and management of children undergoing Pectus Excavatum repair surgery.

研究概览

简要总结

Context: Chest wall deformities in children are relatively common. One such deformity, known as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of these abnormalities - present in approximately 1 out of every 400-1000 births. This deformity is often a cosmetic problem for affected individuals. When severe, PE can also be associated with cardiopulmonary compromise.

Treatment of PE involves surgical correction. There are several potential methods for correcting PE. In the past the most common repair involved an open procedure which involves excision and reshaping of the ribcage. More recently a minimally invasive procedure has been adopted involving the placement of a stainless steel or titanium bar underneath the sternum to reshape the chest wall. This procedure, commonly known as the Nuss procedure, carries with it significant post-operative pain management problems. In fact, the pain issues after Nuss procedure may be more significant than after open repair. The quality of postoperative pain control in these cases has been shown to affect several measurable objective outcomes during hospitalization including capacity for deep breathing, early mobilization, ambulation, and length of hospital stay.

Epidural analgesia (EA) has been one of the standard methods for managing pain in the early postoperative period after PE repair. Unfortunately severe pain may persist after the removal of an epidural catheter resulting in a difficult "transition" period just prior to discharge from the hospital. In addition reports of neurological injury after epidural analgesia for Nuss procedures have appeared. In light of these issues, many institutions have opted for alternative methods of pain control including peripheral nerve blocks, patient controlled analgesia, and wound catheters.

There remains significant debate as to which pain control methodology is best. There is little consistent data available on pain control or outcomes that occur after EA is stopped. Moreover there is reluctance in any one institution to trial or randomize patients to a variety of treatment modalities. For all of these reasons, investigators are proposing participation in a multi-institutional data sharing project concerning the repair of EA in which participating centers will collaborate to better understand the outcomes of perioperative care for patients undergoing correction of this problem.

详细描述

Context: Chest wall deformities in children are relatively common. One such deformity, known as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of these abnormalities - present in approximately 1 out of every 400-1000births. This deformity is often a cosmetic problem for affected individuals. When severe, PE can also be associated with cardiopulmonary compromise.

Treatment of PE involves surgical correction. There are several potential methods for correcting PE. In the past the most common repair involved an open procedure which involves excision and reshaping of the ribcage. More recently a minimally invasive procedure has been adopted involving the placement of a stainless steel or titanium bar underneath the sternum to reshape the chest wall. This procedure, commonly known as the Nuss procedure, carries with it significant post-operative pain management problems. In fact the pain issues after Nuss procedure may be more significant than after open repair. The quality of postoperative pain control in these cases has been shown to affect several measurable objective outcomes during hospitalization including capacity for deep breathing, early mobilization, ambulation, and length of hospital stay.

Epidural analgesia (EA) has been one of the standard methods for managing pain in the early postoperative period after PE repair. Unfortunately severe pain may persist after the removal of an epidural catheter resulting in a difficult "transition" period just prior to discharge from the hospital. In addition reports of neurological injury after epidural analgesia for Nuss procedures have appeared. In light of these issues, many institutions have opted for alternative methods of pain control including peripheral nerve blocks, patient controlled analgesia, and wound catheters. There remains significant debate as to which pain control methodology is best. There is little consistent data available on pain control or outcomes that occur after EA is stopped. Moreover there is reluctance in any one institution to trial or randomize patients to a variety of treatment modalities. For all of these reasons, investigators are proposing participation in a multi-institutional data sharing project concerning the repair of EA in which participating centers will collaborate to better understand the outcomes of perioperative care for patients undergoing correction of this problem.

The primary objective is to create a multicenter registry which captures data relating to the perioperative course and management of children undergoing PE repair surgery. This effort is undertaken in order to augment safety and quality improvement activities at participating sites. Investigators understand that there are multiple methodologies for accomplishing the anesthesia and perioperative pain control for this surgery. There is little comparative data on the outcomes from the different possible management strategies. Given the relative frequencies of these surgeries where few centers perform more than 20-50 of these procedures per year, it is not practical for any one (or two) centers to study this procedure in an observational manner or a controlled randomized trial. Investigators' aggregate multi-institutional data set will be used for benchmarking for both local and national safety and quality improvement efforts. Participating sites will be provided with reports comparing the local site to the aggregate dataset for specific perioperative outcome variables (e.g. pain metrics) and factors that could be associated with improved outcomes. Outcome variables include but are not limited to intraoperative hemodynamics, pain control, emergence agitation, apnea/airway obstruction, hemodynamic stability, time to first ambulation, pain scores while in the hospital, total hospital days, time to school or work attendance, and symptoms of post-traumatic stress.

Secondary objective: Investigators will ultimately look at the relationship between specific management metrics such as the use of epidural anesthesia vs. peripheral nerve blocks vs. local anesthesia wound infiltration and our primary outcome metrics. In addition Investigators will consider the frequency of long term Post Traumatic Stress behaviors and the various measures of pain control in the perioperative period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females ages 8 to 30 years.
  • Undergoing surgical procedures on the chest wall region performed to correct Pectus Excavatum deformities.

排除标准

  • 未提供

结局指标

主要结局

Perioperative course and management of children undergoing Pectus Excavatum repair surgery.

时间窗: Baseline, Daily up to Three Weeks

Peri- and Post-Operative Pain Control

次要结局

  • Perioperative course and management of children undergoing Pectus Excavatum repair surgery.(Up to Three Months After Hospital Discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph P. Cravero

Anesthesiologist

Boston Children's Hospital

研究点 (1)

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