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

NCT ID: NCT04211935

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-27
• Study Completion Date: 2024-06-30

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.

Conditions

Pectus Excavatum; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Use of PCA

Intervention Type: DEVICE

A commercially available PCA pump will be connected to the patient's intravenous line at the end of the MIRPE operation.

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.

Group Type: EXPERIMENTAL

Use of ESB for postoperative pain control after MIRPE

Intervention Type: DEVICE

Pediatric anesthesiologists will place ESB at the time of the MIRPE operation if study participants are randomized into this group.

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.

Group Type: EXPERIMENTAL

Use of INC for postoperative pain control after MIRPE

Intervention Type: DEVICE

Pediatric surgeons will perform INC during the MIRPE operation if they are randomized to this group.

Interventions

Use of PCA

A commercially available PCA pump will be connected to the patient's intravenous line at the end of the MIRPE operation.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Colorado

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natasha Corbitt, MD

Role: STUDY_DIRECTOR

Safety Officer--University of Texas Southwestern

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jose L Diaz-Miron, MD

Role: CONTACT

Phone: 720-777-6571

Email: jose.diaz-miron@childrenscolorado.org

Facility Contacts

Jose L Diaz-Miron, MD

Role: primary

Other Identifiers

19-2794

Identifier Type: -

Identifier Source: org_study_id