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NCT01863498 · ClinicalTrials.gov registry record · NA
Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA
A NA study, sponsored by Children's Mercy Hospital Kansas City.
- Terminated
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT01863498: Clinical Trial NA study, sponsored by Children's Mercy Hospital Kansas City.
NCT01863498 is a NA study that was terminated before completion, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01863498, a NA study, was terminated before completion, sponsored by Children's Mercy Hospital Kansas City.
- TERMINATED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study Summary
Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000 children. Operative repair of the anterior thoracic concavity has transitioned to the minimally invasive approach with substernal bar placement through small axillary incisions (Nuss procedure and multiple modifications). These procedures were quickly incorporated by high volume centers around the world including our own. The operation is certainly quicker and associated with less blood loss than the open operation, but as opposed to most minimally invasive versions of an operation, patients do not leave the hospital sooner after bar placement and experience more post-operative pain. Pain during the post-operative hospital stay is the dominant management issue after bar placement. The sparse literature on the topic has suggested that a thoracic epidural is the most effective means for attenuating the pain during the first few post-operative days. Therefore, most centers approach all patients undergoing a pectus deformity repair with an attempt at epidural placement under the assumption that this provides the most effective strategy for pain control. However, the investigators conducted a retrospective evaluation to examine the validity of this assumption and to investigate whether there is a role for a prospective study to determine the optimum post-operative pain management of these patients. The results demonstrate there was a decreased length of stay in the patients not treated with an epidural (PCA), despite no disadvantage in pain control. Further, 30% in whom an epidural was attempted, catheter placement failed. This data certainly challenges the assumption that an epidural is the optimum management for these patients, and convincingly answers the question as to whether there is a role for a prospective randomized trial.
Primary Outcome
The primary outcome variable is length of hospitalization after the intervention.
Interventions
- OTHER Epidural
- OTHER PCA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-05 |
| Est. Completion | 2019-08 |
| Phase | NA |
Why NCT01863498 stopped before completion
NCT01863498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Epidural is the first listed.
NCT01863498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01863498 about?
NCT01863498 is a clinical study titled "Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA". Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000 children. Operative repair of the anterior thoracic concavity has transitioned to the minimally invasive approach with substernal bar placement through small axillary incisions (Nuss procedure and multiple modifica...
What is the current status of trial NCT01863498?
This trial is currently terminated. It is a NA study. The enrollment target is 65 participants. The study started on 2013-05. Estimated completion is 2019-08.
What interventions are being tested in trial NCT01863498?
The interventions under investigation include: Epidural (OTHER), PCA (OTHER).
Who is sponsoring clinical trial NCT01863498?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01863498's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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