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Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA (PectusEpiPCA)

Primary Purpose

Pectus Excavatum

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural
PCA
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pectus Excavatum focused on measuring pectus excavatum, pain control

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing a pectus excavatum repair with bar placement.
  • Pectus patients between 12 and 17.9 years of age.

Exclusion Criteria:

  • Open repair
  • Re-Do operation
  • Known allergy to a pain medication in the protocol
  • Existing contraindications to epidural catheter placement
  • Requirement for 2 bars to be placed (rare)

Sites / Locations

  • Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PCA pain control

Epidural pain control

Arm Description

Patients will have PCA for pain control

Patients will have an epidural for pain control

Outcomes

Primary Outcome Measures

Length of Hospitalization After Surgery
The primary outcome variable is length of hospitalization after the intervention.

Secondary Outcome Measures

Operation Time
Duration of operation in minutes
Total Operating Room Time
Total operating room time in minutes

Full Information

First Posted
February 15, 2013
Last Updated
October 9, 2020
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT01863498
Brief Title
Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA
Acronym
PectusEpiPCA
Official Title
Prospective Randomized Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Institution converted to an alternative strategy for pain control
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000 children. Operative repair of the anterior thoracic concavity has transitioned to the minimally invasive approach with substernal bar placement through small axillary incisions (Nuss procedure and multiple modifications). These procedures were quickly incorporated by high volume centers around the world including our own. The operation is certainly quicker and associated with less blood loss than the open operation, but as opposed to most minimally invasive versions of an operation, patients do not leave the hospital sooner after bar placement and experience more post-operative pain. Pain during the post-operative hospital stay is the dominant management issue after bar placement. The sparse literature on the topic has suggested that a thoracic epidural is the most effective means for attenuating the pain during the first few post-operative days. Therefore, most centers approach all patients undergoing a pectus deformity repair with an attempt at epidural placement under the assumption that this provides the most effective strategy for pain control. However, the investigators conducted a retrospective evaluation to examine the validity of this assumption and to investigate whether there is a role for a prospective study to determine the optimum post-operative pain management of these patients. The results demonstrate there was a decreased length of stay in the patients not treated with an epidural (PCA), despite no disadvantage in pain control. Further, 30% in whom an epidural was attempted, catheter placement failed. This data certainly challenges the assumption that an epidural is the optimum management for these patients, and convincingly answers the question as to whether there is a role for a prospective randomized trial.
Detailed Description
Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000 children.1 Operative repair of the anterior thoracic concavity has transitioned to the minimally invasive approach with substernal bar placement through small axillary incisions (Nuss procedure and multiple modifications). These procedures were quickly incorporated by high volume centers around the world including our own.2-7 The operation is certainly quicker and associated with less blood loss than the open operation, but as opposed to most minimally invasive versions of an operation, patients do not leave the hospital sooner after bar placement and experience more post-operative pain.6,7,8 Pain during the post-operative hospital stay is the dominant management issue after bar placement. The sparse literature on the topic has suggested that a thoracic epidural is the most effective means for attenuating the pain during the first few post-operative days.10-12 Therefore; most centers approach all patients undergoing a pectus deformity repair with an attempt at epidural placement under the assumption that this provides the most effective strategy for pain control.3-9, 13 However, the investigator conducted a retrospective evaluation to examine the validity of this assumption and to investigate whether there is a role for a prospective study to determine the optimum post-operative pain management of these patients.14 The investigator found length of stay was shorter with PCA and pain scores were similar. What the investigator found certainly challenges the assumption that an epidural is the optimum management for these patients, and convincingly answered the question as to whether there is a role for a prospective randomized trial. The investigator conducted the prospective, randomized trial in 110 patients.15 The investigator found the pain scores were better with epidural for the first 2 days and better with PCA the last 2 days. There was no difference in length of stay although it trended to favor PCA. Epidural group incurred far greater operation times and charges. The pragmatic interpretation was that the investigator should just use PCA. The anesthesia interpretation is that the investigator need a better epidural. Therefore, the investigator have developed a better protocol for the transition to try to improve pain control the last 2 days. Further, the investigator recognize several flaws in the last study; the investigator included patients at extremes of age which don't represent a normal course. Second, the investigator kept patients in the hospital until they had a bowel movement which may have prolonged the care unnecessarily in the PCA group. The investigator will use the same sample size as last time since the difference in length of stay the investigator were designed to detect was more than a day which is clinically relevant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum
Keywords
pectus excavatum, pain control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCA pain control
Arm Type
Active Comparator
Arm Description
Patients will have PCA for pain control
Arm Title
Epidural pain control
Arm Type
Active Comparator
Arm Description
Patients will have an epidural for pain control
Intervention Type
Other
Intervention Name(s)
Epidural
Intervention Description
Patients will have an epidural for pain control
Intervention Type
Other
Intervention Name(s)
PCA
Intervention Description
Patients will have PCA for pain control
Primary Outcome Measure Information:
Title
Length of Hospitalization After Surgery
Description
The primary outcome variable is length of hospitalization after the intervention.
Time Frame
3-8 days
Secondary Outcome Measure Information:
Title
Operation Time
Description
Duration of operation in minutes
Time Frame
Duration of operation, an average of 1 hour
Title
Total Operating Room Time
Description
Total operating room time in minutes
Time Frame
Duration of time in operating room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing a pectus excavatum repair with bar placement. Pectus patients between 12 and 17.9 years of age. Exclusion Criteria: Open repair Re-Do operation Known allergy to a pain medication in the protocol Existing contraindications to epidural catheter placement Requirement for 2 bars to be placed (rare)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D St. Peter, MD
Organizational Affiliation
Children's Mercy Hospital and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA

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