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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 is a NA study that was terminated before completion, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 65 participants.

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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.

Interventions

  • OTHER Epidural
  • OTHER PCA

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2013-05
Est. Completion 2019-08
Phase NA

What the Registry Record Tells You About NCT01863498

The ClinicalTrials.gov registry entry for NCT01863498 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Epidural is the first listed.

NCT01863498 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.