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NCT04211935 · ClinicalTrials.gov registry record · NA
Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum
A NA study, sponsored by University of Colorado, Denver.
- Active
- Registry status
- NA
- Development phase
- 158
- Enrollment target
NCT04211935 is a NA study that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 158 participants.
The verdict
NCT04211935, a NA study, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 158 participants
- Enrollment target
Study Summary
Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usually performed in the teenage years. A common operative procedure to repair a pectus deformity is the minimally invasive repair of pectus excavatum (MIRPE). The MIRPE involves the substernal placement of a contoured metal bar secured to the lateral aspect of the ribs. This metal bar allows for correction of the concave deformity by applying constant outward pressure to the underside of the sternum. Although the cosmetic results are excellent, patients do report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches tend to differ on both the provider and institutional level. There is a lack of evidence regarding which postoperative analgesia method is best. To address this research gap, this proposal aims to conduct a randomized controlled trail using the three most commonly used methods; 1) patient controlled analgesia (PCA); 2) erector spinae blocks (ESB) with continuous infusion pumps; and 3) video-assisted intercostal nerve cryoablation (INC).
Interventions
- DEVICE Use of PCA
- DEVICE Use of ESB for postoperative pain control after MIRPE
- DEVICE Use of INC for postoperative pain control after MIRPE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2020-05-27 |
| Est. Completion | 2027-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04211935
The ClinicalTrials.gov registry entry for NCT04211935 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Use of PCA is the first listed.
NCT04211935 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04211935 about?
NCT04211935 is a clinical study titled "Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum". Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usua...
What is the current status of trial NCT04211935?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 158 participants. The study started on 2020-05-27. Estimated completion is 2027-12.
What interventions are being tested in trial NCT04211935?
The interventions under investigation include: Use of PCA (DEVICE), Use of ESB for postoperative pain control after MIRPE (DEVICE), Use of INC for postoperative pain control after MIRPE (DEVICE).
Who is sponsoring clinical trial NCT04211935?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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