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

NCT01863498 | Terminated Results

• 1 other identifier: 12120535
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum

Keywords

pectus excavatum; pain control

Outcome Measures

Primary Outcomes (1)

• Length of Hospitalization After Surgery

  The primary outcome variable is length of hospitalization after the intervention.

  3-8 days

Secondary Outcomes (2)

• Operation Time

  Duration of operation, an average of 1 hour

• Total Operating Room Time

  Duration of time in operating room

Study Arms (2)

PCA pain control

ACTIVE COMPARATOR

Patients will have PCA for pain control

Other: PCA

Epidural pain control

ACTIVE COMPARATOR

Patients will have an epidural for pain control

Other: Epidural

Interventions

Epidural OTHER

Patients will have an epidural for pain control

Epidural pain control

PCA OTHER

Patients will have PCA for pain control

PCA pain control

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Funnel Chest; Agnosia

Interventions

Injections, Epidural; Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Results Point of Contact

• Title: Dr. Shawn St. Peter
• Organization: Children's Mercy Kansas City

sspeter@cmh.edu

816-234-3575

Study Officials

• Shawn D St. Peter, MD

  Children's Mercy Hospital and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: May 29, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: August 1, 2019
• Last Updated: November 3, 2020
• Results First Posted: November 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)