Sub-Paraspinal Block in Nuss Patients. A Pilot Project
Completed · Phase 4
Conditions studied: Pectus Excavatum, Pain, Postoperative
In brief
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.
Key facts
- Study ID
- NCT02169297
- Run by
- Nemours Children's Clinic
- People needed
- 10
- Starts
- 2011-11-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2014-06-23
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children undergoing the Nuss procedure were considered for the study and were approached during their preoperative anesthesia evaluation.
You may not qualify if…
- Contraindication to the study medications
- Preexisting chronic pain disorder.
Where it is running
- Wolfson Children's Hospital, Baptist Medical Center Downtown — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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