Nuss Procedure: Clinical Options in Pediatric Pain Management?

Pectus Excavatum Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009267
• Other study ID #: IRB13-00702
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: February 1, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

Device:
• Patient controlled analgesia
A programable electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button.

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) is the technique of injecting local anesthetic adjacent to the thoracic vertebra that anesthetizes the spinal nerve roots after they exit the spinal canal.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ralph Beltran

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score	Pain scores obtained from the visual analog scale.	Participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary	Length of hospitalization	Determine if there is a difference in length of hospitalization, and time to discharge.	Within the first week after surgery.
Secondary	Nausea and vomiting	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