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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pectus Excavatum
• Intervention / Treatment: Other: PCA; Other: Epidural

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCA pain control; Patients will have PCA for pain control	Other: PCA; Patients will have PCA for pain control
Active Comparator: Epidural pain control; Patients will have an epidural for pain control	Other: Epidural; Patients will have an epidural for pain control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospitalization After Surgery	The primary outcome variable is length of hospitalization after the intervention.	3-8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation Time	Duration of operation in minutes	Duration of operation, an average of 1 hour
Total Operating Room Time	Total operating room time in minutes	Duration of time in operating room

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: February 15, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 29, 2013

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pectus excavatum; pain control
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: 12120535

Plan for Individual participant data (IPD)

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