N/A
N=85
Post Operative Pain Control Using Ropivacaine and the ON-Q System in the Adult Pectus Excavatum Patient
Pectus Excavatum
Bottom Line
View on ClinicalTrials.gov: NCT01816477 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Hospital Length of Stay — 3.5; 3.3 days — p=0.55
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ON-Q soaker catheter system (Device); Epidural (ropivicaine 0.25%) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Length of Stay |
3.5; 3.3 | 0.55 |
| PRIMARY Use of Analgesic Narcotic |
40.8; 58.7; 99.5; 107.2; 79.7; 62.4 | 0.0872 |
| SECONDARY Mean Daily Pain Score |
2.19; 2.39; 2.64; 2.60; 3.16; 2.97 | 0.6465 |
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. 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. 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. 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 and patients are suitable for discharge.
It is hypothesized that using the ON-Q 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 ON-Q system versus epidural.
Eligibility Criteria
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
- Must be able to take oral medications preoperatively and postoperatively.
Exclusion Criteria
- American Society of Anesthesiology class IV or higher
- Allergic to Ropivacaine or other local anesthetics
- NSAID allergy
- Specific epidural contraindication
- Currently using opioids, sedatives, or hypnotics
- Are pregnant as verified by preoperative pregnancy testing
- Inability to place an epidural, patient refusal for epidural, or failure of an epidural to be properly placed or maintain proper placement for adequate pain control.
Data sourced from ClinicalTrials.gov (NCT01816477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.