Nuss Procedure: Clinical Options in Pediatric Pain Management?
1 other identifier
observational
32
1 country
1
Brief Summary
A retrospective chart review study analyzing the benefits of patient controlled analgesia, thoracic epidural analgesia, and paravertebral nerve block catheters in patients having surgical repair of pectus excavatum using the Nuss procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 2, 2017
February 1, 2017
3.1 years
November 19, 2013
February 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Total morphine dose
Total morphine dose will be evaluated in mg/kg/24 hour period, beginning with post-op day 0 until discharge from the hospital.
Participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary Outcomes (3)
Pain score
Participants will be followed for the duration of hospital stay, an expected average of 3 days
Length of hospitalization
Within the first week after surgery.
Nausea and vomiting
0-48 hrs. post-op
Study Arms (3)
Patient controlled analgesia
Use of patient controlled analgesia (PCA) for the management of postoperative pain after the Nuss procedure.
Continuous thoracic epidural infusion
Continuous thoracic epidural infusions (TE) for the management of postoperative pain after the Nuss procedure.
Continuous paravertebral blockade
Continuous paravertebral blockade (PVB) for the management of postoperative pain after the Nuss procedure.
Interventions
A programable electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button.
Continuous thoracic epidural infusions (TE) involves continuous infusion of drugs through a catheter placed into the epidural space, resulting in a loss of sensation-including the sensation of pain-by blocking the transmission of signals through nerve fibers in or near the spinal cord.
Continuous paravertebral blockade (PVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra that anesthetizes the spinal nerve roots after they exit the spinal canal.
Eligibility Criteria
Patients undergoing the Nuss procedure to correct pectus excavatum at Nationwide Children's Hospital.
You may qualify if:
- Patients undergoing the NUSS procedure since the beginning of 2011 to Sept. 30th, 2013.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ralph Beltranlead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beltran Ralph, MD
Nationwide Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Clinical Professor
Study Record Dates
First Submitted
November 19, 2013
First Posted
December 11, 2013
Study Start
November 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 2, 2017
Record last verified: 2017-02