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Pectus ExcavatumPectusEpiPCANCT01863498

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

A study testing Epidural and PCA in people with Pectus Excavatum, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Pectus Excavatum
What is being tested?
Epidural and PCA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
May 2013to Aug 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Epidural, PCA
Keywords
pectus excavatum, pain control
Medical subject headings
Funnel Chest, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpiduralOther

    Patients will have an epidural for pain control

  • PCAOther

    Patients will have PCA for pain control

Study groups in NCT01863498
Study groupRoleWhat they receive
PCA pain controlActive comparatorPatients will have PCA for pain control
Receives: Other: PCA
Epidural pain controlActive comparatorPatients will have an epidural for pain control
Receives: Other: Epidural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of Hospitalization After Surgery

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

    Measured: 3-8 days

Secondary outcomes (2)
  1. Operation Time

    Duration of operation in minutes

    Measured: Duration of operation, an average of 1 hour

  2. Total Operating Room Time

    Total operating room time in minutes

    Measured: Duration of time in operating room

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJan 2018
  4. Study completionAug 2019

Why it stopped: Institution converted to an alternative strategy for pain control

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01863498
Sponsor's protocol ID
12120535
Acronym
PectusEpiPCA
Status last verified
Aug 2020
First submitted
15 Feb 2013
Last updated
3 Nov 2020
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Epidural and PCA in people with Pectus Excavatum, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Hospitalization After Surgery (time frame: 3-8 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.

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