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

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ClinicalTrials.gov Identifier: NCT01863498
Recruitment Status : Recruiting
First Posted : May 29, 2013
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Pectus Excavatum Other: Epidural Other: PCA

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Randomized Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA
Study Start Date : May 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Length of hospitalization after surgery [ Time Frame: 5-10 days ]
    The primary outcome variable is length of hospitalization after the intervention.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863498


Contacts
Contact: Shawn D St. Peter, MD 816-983-6479 sspeter@cmh.edu
Contact: Susan W Sharp, PhD 816-983-6670 swsharp@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn D St. Peter, MD    816-983-6479    sspeter@cmh.edu   
Contact: Susan W Sharp, PhD    816-983-6670    swsharp@cmh.edu   
Principal Investigator: Shawn D St. Peter, MD         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital and Clinics
More Information

Responsible Party: Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01863498     History of Changes
Other Study ID Numbers: 12120535
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
pectus excavatum
pain control

Additional relevant MeSH terms:
Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities