Clinical trial NCT04211935: Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum
Official title: The Use of Video-assisted Intercostal Nerve Cryoablation, Erector Spinae Block, and Thoracic Epidural for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pectus Excavatum
Pain, Postoperative
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2019-12-26
Enrollment: 158
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usually performed in the teenage years. A common operative procedure to repair a pectus deformity is the minimally invasive repair of pectus excavatum (MIRPE). The MIRPE involves the substernal placement of a contoured metal bar secured to the lateral aspect of the ribs. This metal bar allows for correction of the concave deformity by applying constant outward pressure to the underside of the sternum. Although the cosmetic results are excellent, patients do report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches tend to differ on both the provider and institutional level. There is a lack of evidence regarding which postoperative analgesia method is best. To address this research gap, this proposal aims to conduct a randomized controlled trail using the three most commonly used methods; 1) patient controlled analgesia (PCA); 2) erector spinae blocks (ESB) with continuous infusion pumps; and 3) video-assisted intercostal nerve cryoablation (INC).

Detailed description: Pectus excavatum deformity is a common condition in a pediatric surgical practice. While MIRPE provides excellent cosmetic results and is associated with shorter operative time and lower intraoperative blood loss, the immediate correction of the concave deformity with a metal bar places patients in a difficult pain control situation. While multiple postoperative analgesia modalities have been studied, there is still a need for a large, prospective, randomized trial that is appropriately powered to evaluate the best pain control modality after MIRPE. Of the clinically appropriate interventions, ESB and INC have been shown to have comparable LOS after the operation, especially when employed as part of an enhanced recovery pathway (ERP) bundle. Comparing these newer analgesia modalities to the more established PCA approach may help identify the most effective postoperative pain control approach that maximizes the safety profile while minimizing the use of narcotic pain medications after MIRPE.

The investigators propose a prospective randomized trial evaluating the effectiveness of INC, PCA and ESB with continuous local anesthetic infusion via a pain pump delivery system. All groups will follow a multimodal enhanced recovery pathway. Groups will different only in the use of INC, PCA, or ESB.

Since previous studies have reported similarly short LOS for both ESB and INC, but no prospective, direct comparisons of these techniques have been done, we believe comparing these two groups to the more established PCA modality will further advance the field of post MIRPE pain management by providing precise estimates of length of stay (LOS), hospital resource utilization, and other important outcomes that have not received sufficient attention including pain, quality of life, resumption of activities of daily living, and a rigorous survey for potential adverse outcomes. The investigators specifically hypothesize that because of the long-term analgesia of up to 2-3 months, the INC group may experience not only shorter LOS but decreased narcotic use than the ESB and PCA groups, and also improved quality of life, with fewer encounters in the postoperative period (30 days) for pain related concerns.

Eligibility criteria: Inclusion Criteria:

* All patients with a pectus excavatum deformity that will undergo a MIRPE procedure will be included in the study.

Exclusion Criteria:

* \< 13 years old
* \> 18 years old
* chronic narcotic preoperative use
* previous repair of pectus excavatum deformity
* previous thoracic surgery
* pregnancy

Primary outcomes:
measure: Length of Stay
timeFrame: 24 months
Secondary outcomes:
measure: Total intravenous and oral opioid use
timeFrame: 24 months
measure: Postoperative pain
timeFrame: 24 months
measure: Quality of life after MIRPE
timeFrame: 24 months
measure: Complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Safety Officer--University of Texas Southwestern
name: Natasha Corbitt, MD
role: STUDY_DIRECTOR
References: