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

Primary Purpose

Pectus Excavatum, Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of PCA
Use of ESB for postoperative pain control after MIRPE
Use of INC for postoperative pain control after MIRPE
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pectus Excavatum

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patient Controlled Analgesia

Erector Spinae Block

Intercostal Nerve Cryoablation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Length of Stay
The investigators will measure the total length of stay following the operation until discharge from the hospital.

Secondary Outcome Measures

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.
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).
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
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.

Full Information

First Posted
December 23, 2019
Last Updated
February 16, 2023
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT04211935
Brief Title
Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum
Acronym
(MIRPE)
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Participants will be randomly assigned to one of three interventional groups. Study participants and team members will be blinded on randomized group until entering the operating room, at which point the cryoablation machine and instruments will be brought into the room for INC or the anesthesiologist will place ESB. The PCA pump will be connected to the patient's intravenous line at the end of the case.
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Controlled Analgesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Erector Spinae Block
Arm Type
Experimental
Arm Description
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.
Arm Title
Intercostal Nerve Cryoablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Use of PCA
Intervention Description
A commercially available PCA pump will be connected to the patient's intravenous line at the end of the MIRPE operation.
Intervention Type
Device
Intervention Name(s)
Use of ESB for postoperative pain control after MIRPE
Intervention Description
Pediatric anesthesiologists will place ESB at the time of the MIRPE operation if study participants are randomized into this group.
Intervention Type
Device
Intervention Name(s)
Use of INC for postoperative pain control after MIRPE
Intervention Description
Pediatric surgeons will perform INC during the MIRPE operation if they are randomized to this group.
Primary Outcome Measure Information:
Title
Length of Stay
Description
The investigators will measure the total length of stay following the operation until discharge from the hospital.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Total intravenous and oral opioid use
Description
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.
Time Frame
24 months
Title
Postoperative pain
Description
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).
Time Frame
24 months
Title
Quality of life after MIRPE
Description
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
Time Frame
24 months
Title
Complications
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose L Diaz-Miron, MD
Phone
720-777-6571
Email
jose.diaz-miron@childrenscolorado.org
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose L Diaz-Miron, MD
Phone
720-777-6571
Email
jose.diaz-miron@childrenscolorado.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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