12.08 Pectus Excavatum-To Randomize or Not To Randomize

B. G. Dalton1, K. W. Schnell1, A. A. Desai1, S. W. Sharp1, S. D. St. Peter1  1Children’s Mercy Hospital- University Of Missouri Kansas City,Pediatric Surgery,Kansas City, MO, USA

Introduction:  Minimally invasive bar repair for pectus patients produces substantial pain which dictates the post-operative hospital course.  We conducted a randomized trial comparing epidural catheter placement to patient controlled analgesia and second trial comparing these 2 strategies is under way.  The purpose of this study was to compare the outcomes of patients who were enrolled in the trials to those did not participate in the trials. 

Methods:  A retrospective chart review was performed on patients not enrolled in the trials to compare to the prospective datasets from October 2006 to June 2014.  Perioperative outcomes including length of stay (LOS), pain scores, time to PO diet, operative time and complication rate were examined.  Pain scores were calculated with a visual analog system (VAS).  Findings are reported in mean ± standard deviations.  Comparative analysis was performed using student t test

Results: There were 135 patients in a study protocol (IS) and 195 patients that were not enrolled in a study (OS).  Of the IS patients, 23.4% (n=15 of 64) had epidural failure for pain control compared to 45.9% (n=17 of 37) of OS patients (p<0.01).  In the PCA groups LOS was less in the IS group vs OS group (4.5d vs 4.1d, p=0.02).  Comparing the entire IS and OS groups, LOS was less in the IS group, as was time to PO diet. Average pain scores, operative time and complication rates, including bar malposition, bar infection and wound infection, were not significantly different between the groups (table).

Conclusion

There are clear clinical benefits derived from participating in our randomized trials comparing epidural to patient controlled analgesia after bar placement for pectus excavatum regardless of which arm is utilized.