SPAIN Chest Wall Deformity Project (Pectus Repair)

Summary

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.

Conditions

• Deformity of Chest Wall

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Alfred I. duPont Hospital for Children

  collaborator OTHER

• Emory University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Joseph P Cravero, MD · Boston Children's Hospital

Eligibility

Min Age

8 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2015-10-20

Completion

2018-09-30

Countries

• United States

Study Locations