Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient After Minimally Invasive Repair
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 12-008050
NCT ID: NCT01816477
Sponsor Protocol Number: 12-008050
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Dawn Jaroszewski, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available