Nuss Procedure: Clinical Options in Pediatric Pain Management?

February 1, 2017 updated by: Ralph Beltran
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing the Nuss procedure to correct pectus excavatum at Nationwide Children's Hospital.

Description

Inclusion Criteria:

  • Patients undergoing the NUSS procedure since the beginning of 2011 to Sept. 30th, 2013.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient controlled analgesia
Use of patient controlled analgesia (PCA) for the management of postoperative pain after the Nuss procedure.
Device: Patient controlled analgesia
A programable electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button.
Continuous thoracic epidural infusion
Continuous thoracic epidural infusions (TE) for the management of postoperative pain after the Nuss procedure.
Procedure: Continuous thoracic epidural infusions
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
Continuous paravertebral blockade (PVB) for the management of postoperative pain after the Nuss procedure.
Procedure: Continuous paravertebral blockade
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine dose
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Pain scores obtained from the visual analog scale.
Participants will be followed for the duration of hospital stay, an expected average of 3 days
Length of hospitalization
Time Frame: Within the first week after surgery.
Determine if there is a difference in length of hospitalization, and time to discharge.
Within the first week after surgery.
Nausea and vomiting
Time Frame: 0-48 hrs. post-op
Determine the incidence of nausea and vomiting measured by the postoperative ondansetron dosing, beginning with arrival to floor and up to the first 48 hrs of hospitalization.
0-48 hrs. post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ralph Beltran

Investigators

  • Principal Investigator: Beltran Ralph, MD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB13-00702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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