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NCT02098681 · ClinicalTrials.gov registry record
SPAIN Chest Wall Deformity Project (Pectus Repair)
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 348
- Enrollment target
NCT02098681: Completed study, sponsored by Boston Children's Hospital.
NCT02098681 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 348 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02098681 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 348 participants
- Enrollment target
Study 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 afte
Primary Outcome
Peri- and Post-Operative Pain Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2014-01 |
| Est. Completion | 2018-09 |
What the finished NCT02098681 record still lists
NCT02098681 is an observational study that tracks outcomes without assigning an intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02098681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02098681 about?
NCT02098681 is a clinical study titled "SPAIN Chest Wall Deformity Project (Pectus Repair)". 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 probl...
What is the current status of trial NCT02098681?
This trial is currently completed. The enrollment target is 348 participants. The study started on 2014-01. Estimated completion is 2018-09.
Who is sponsoring clinical trial NCT02098681?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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