Nuss Procedure: Clinical Options in Pediatric Pain Management?

Completed

• Conditions: Pectus Excavatum
• Interventions: Device: Patient controlled analgesia; Procedure: Continuous thoracic epidural infusions; Procedure: Continuous paravertebral blockade

• Registration Number: NCT02009267
• Lead Sponsor: Ralph Beltran

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient controlled analgesia	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	Continuous thoracic epidural infusions (TE) for the management of postoperative pain after the Nuss procedure.
Continuous paravertebral blockade	Continuous paravertebral blockade	Continuous paravertebral blockade (PVB) for the management of postoperative pain after the Nuss procedure.

Primary Outcome Measures

Name	Time	Method
Total morphine dose	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States