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NCT02169297 · ClinicalTrials.gov registry record · Phase 4
Sub-Paraspinal Block in Nuss Patients. A Pilot Project
A Phase 4 study of Pain, Postoperative and Pectus Excavatum, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02169297: Completed Phase 4 study of Pain, Postoperative and Pectus Excavatum, sponsored by Nemours Children's Clinic.
NCT02169297 is a Phase 4 study of Pain, Postoperative and Pectus Excavatum that has completed, run by Nemours Children's Clinic. The registered enrollment target is 10 participants, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02169297, a Phase 4 study of Pain, Postoperative and Pectus Excavatum, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this pilot study was to evaluate effectiveness of a novel regional anesthesia technique developed at the investigators institution, as part of a quality improvement initiative, to assist with multilevel thoracic pain control in post-Nuss procedure patients. The investigators hypothesized that the local anesthetic infusion via bilateral multiperforated soaker catheters placed at extrathoracic sub-paraspinal muscle location under ultrasound guidance would significantly improve pain control, as reflected by the decrease in pain intensity score, reduction in opiate requirement and improvement infunctional rehabilitation measure scores in patients who underwent the Nuss procedure for pectus excavatum repair. However, the goal of this pilot study was not to detect a statistically significant difference in the primary outcomes between control and treatment groups (as the number of study subjects was chosen out of necessity of what could be completed within a specified time period), but to estimate the parameters which allows appropriate power and sample size calculations for a future multi-institutional study.
Primary Outcome
Narcotic requirement was recorded in the PACU and at 6 hour intervals through 48 hours from the time of arrival to PACU
Conditions Studied
Interventions
- PROCEDURE Ultrasound-guided Sub-Paraspinal Block
- PROCEDURE PCA only
Study Locations (1)
Florida
- Wolfson Children's Hospital, Baptist Medical Center Downtown - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
What the finished NCT02169297 record still lists
NCT02169297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Ultrasound-guided Sub-Paraspinal Block is the first listed.
NCT02169297 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02169297 about?
NCT02169297 is a clinical study titled "Sub-Paraspinal Block in Nuss Patients. A Pilot Project". The purpose of this pilot study was to evaluate effectiveness of a novel regional anesthesia technique developed at the investigators institution, as part of a quality improvement initiative, to assist with multilevel thoracic pain control in post-Nuss procedure patients. The investigators hypothesi...
What is the current status of trial NCT02169297?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2011-11. Estimated completion is 2014-04.
What conditions does trial NCT02169297 study?
This clinical trial studies the following conditions: Pain, Postoperative, Pectus Excavatum.
What interventions are being tested in trial NCT02169297?
The interventions under investigation include: Ultrasound-guided Sub-Paraspinal Block (PROCEDURE), PCA only (PROCEDURE).
Who is sponsoring clinical trial NCT02169297?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02169297 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02169297's enrollment target sits among peer trials
10 112th of 113 the lowest of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative 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.
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