P2D316: A Randomized Controlled Trial for Postoperative Pain Management After Minimally Invasive Repair of Pectus Excavatum: Initial Experience and Recruitment

Background: Pectus excavatum is the most common pediatric chest wall deformity. Minimally invasive repair of pectus excavatum (MIRPE) utilizes placement of a substernal contoured metal bar for operative correction. Although the cosmetic results are excellent, patients report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches differ on the provider and institutional levels and evidence is lacking regarding the optimal postoperative analgesia method. To address this, we are conducting a randomized controlled trial (RCT) to compare our institution’s three most commonly used methods: 1) multimodal analgesia (MA) only; 2) erector spinae block (ESB) with MA; and 3) intercostal nerve cryoablation (INC) with MA.

Methods: We are conducting an RCT of patients undergoing MIRPE at an academic children’s hospital using MA, ESB+MA, or INC+MA for postoperative analgesia. We anticipate recruiting 42 patients per group for the final statistical analysis. Enrollment began in May 2020. Our primary outcome is hospital length of stay and secondary outcomes include total intravenous and oral opioid use, postoperative pain scores, quality of life, and complications which are assessed via multiple postoperative phone calls for one year following surgery.

Results: To date, we have enrolled 53 participants in this study: 17 each in the INC+MA and MA groups and 19 in the ESB+MA group. Among the enrolled cohort, average age at the time of surgery is 16 years, 89% of participants are male, and 16% are of Hispanic ethnicity. Median Haller index overall is 4.2 and a small minority of patients have a history of a connective tissue disorder (Table 1). Study visit completion at one year was possible in 77.8% (28/36) of all that were enrolled and have reached one year postoperatively.

Conclusion: We are conducting a randomized controlled trial to evaluate three different postoperative analgesia modalities for pectus excavatum repair. Here, we describe our ongoing trial and report our initial experience with recruitment and follow-up.