Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient After Minimally Invasive Repair

Pectus Excavatum Clinical Trial

Official title:

A Prospective, Randomized, Controlled Trial of Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient After Minimally Invasive Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816477
• Other study ID #: 12-008050
• Status: Completed
• Phase: Phase 4
• First received: February 28, 2013
• Last updated: March 28, 2016
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Pectus excavatum (PE) is a common chest wall deformity where the sternum is displaced posteriorly. In severe cases, surgery is performed to correct the defect (1). In recent years, minimally invasive surgery with the placement of stainless steel support bars has been increasingly performed in patients over the age of 17 years (1-9). Because of the decreased malleability and tremendous pressure required to hold the chest wall in the corrected position, post-operative pain control has been a significant problem in this patient population (2,6,9-12). Thoracic epidurals are commonly employed however mean hospitalizations of up to 7 days have been required before adequate pain control on oral analgesics is obtained (3-5, 13) and patients are suitable for discharge.

It is hypothesized that using the ONQ system (I-Flow Corporation, Lake Forest CA) with bilateral intercostal catheter infusion would provide adequate post operative pain control with a significantly shorter hospital length-of-stay than thoracic epidural. Total use of narcotics for 1 week following surgery would also be less with the ONQ system versus epidural.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who are scheduled for repair of their pectus excavatum with minimally invasive (MIRPE) placement of steel or titanium braces at Mayo Clinic Arizona

• Patients who are 18-80 years old

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Funnel Chest
• Pain, Postoperative
• Pectus Excavatum

Intervention

Device:
• ON-Q soaker catheter system

• Epidural (ropivicaine .25%)

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona (MCSB and MCH)	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of analgesic narcotic		1-7 days post operation	No
Primary	Hospital length of stay		Up to 7 day post operation	No
Secondary	Visual analogue scale (VAS) score		Days 1-7 post operation	No
Secondary	Patient satisfaction with pain control	The satisfaction is measured by asking patients "Was it worth it?". A yes/no response will be collected from each patient.	7 days post operation	No
Secondary	Readmission to hospital or emergency room for pain control		Up to 3 months post operation	No
Secondary	Contact with surgical staff for pain related issues after discharge		Up to 3 months post operation	No