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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 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 108 other Pain, Postoperative trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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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.

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

FieldValue
Enrollment Target 10 participants
Start Date 2011-11
Est. Completion 2014-04
Phase Phase 4

Sponsor

Nemours Children's Clinic

108 total trials

What the Registry Record Tells You About NCT02169297

The ClinicalTrials.gov registry entry for NCT02169297 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 273-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (96% lower). The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

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