Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum ((MIRPE))

The Use of Video-assisted Intercostal Nerve Cryoablation, Erector Spinae Block, and Thoracic Epidural for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum

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).

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Pectus Excavatum
• Intervention / Treatment: Device: Use of PCA; Device: Use of ESB for postoperative pain control after MIRPE; Device: Use of INC for postoperative pain control after MIRPE

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.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose L Diaz-Miron, MD; Phone Number: 720-777-6571; Email: jose.diaz-miron@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Jose L Diaz-Miron, MD; Phone Number: 720-777-6571; Email: jose.diaz-miron@childrenscolorado.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Controlled Analgesia; This technique involves connecting a patient controlled analgesia pump to the intravenous line. The patient has the ability to push a button to obtain a predetermined dose of an intravenous opioid with a set lockout time period to minimize the potential for over sedation. PCA pumps will be connected to the intravenous line of the patient at the end of the MIRPE operation. anesthesiologists with experience in regional anesthesia.	Device: Use of PCA; A commercially available PCA pump will be connected to the patient's intravenous line at the end of the MIRPE operation.
Experimental: Erector Spinae Block; This method consists of the anesthesiologist placing two catheters on each side of the vertebrae which then delivers pain medicine continuously via pumps for 2-3 days post-surgery.	Device: Use of ESB for postoperative pain control after MIRPE; Pediatric anesthesiologists will place ESB at the time of the MIRPE operation if study participants are randomized into this group.
Experimental: Intercostal Nerve Cryoablation; The INC technique relies on multilevel freezing of the intercostal neurovascular bundle intraoperatively to block sensation and pain for approximately 2 months postoperatively. Trained pediatric surgeons will perform the INC at the time of a MIRPE procedure.	Device: Use of INC for postoperative pain control after MIRPE; Pediatric surgeons will perform INC during the MIRPE operation if they are randomized to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	The investigators will measure the total length of stay following the operation until discharge from the hospital.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intravenous and oral opioid use	The investigators will quantify the total opioid usage during the hospitalization and also at home and will convert the total results to morphine equivalences for standardization.	24 months
Postoperative pain	The investigators will use reported pain scores to quantify this measure. Scale of 0-10 (0=no pain, 10=worst pain experienced). The investigators will also ask about chest numbness for those in the INC group and will report it on a 0-100% scale (0%=no numbness at all, 100%=completely numb or absent of any sensation).	24 months
Quality of life after MIRPE	The investigators will use a questionnaire to identify if patients are back to baseline and performing their activities of daily living. The investigators will also ask about resumption of any sports related activities after the appropriate postoperative restriction timeframe has passed. This will be a multiple choice questionnaire that will record if 1) they are back to baseline, 2) they are almost back to baseline, 3) they are not back to baseline at all. The investigators will also ask in a multiple choice manner if they have resumed their activities of daily living. The possible answers will be 1) Yes, 2) Incorporating some of the preoperative activities, 3) No	24 months
Complications	The investigators will ask patients about postoperative complications when they are at home. We will also refer back to the chart for any complications that occur during the initial postoperative period or those that have required a readmission after the initial operation.	24 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado
• Investigators: Study Director: Natasha Corbitt, MD, Safety Officer--University of Texas Southwestern

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Pain, Postoperative; Funnel Chest
• Other Study ID Numbers: 19-2794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes