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TerminatedNCT01863498PectusEpiPCAUpdated Nov 3, 2020Results posted

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

An interventional study of Epidural and PCA in Pectus Excavatum, sponsored by Children's Mercy Hospital Kansas City. Terminated at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Supportive care

Why this study was terminated
Institution converted to an alternative strategy for pain control
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Pectus Excavatum

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Keywords

  • pectus excavatum
  • pain control
03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's enrollment of 65 is above the median of 40 across 46 interventional studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Open repair
  • Re-Do operation
  • Known allergy to a pain medication in the protocol
  • Existing to epidural catheter placement
  • Requirement for 2 bars to be placed (rare)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    PCA pain control

    Patients will have PCA for pain control

    Other: PCA

  • Active comparator
    Epidural pain control

    Patients will have an epidural for pain control

    Other: Epidural

Interventions

  • OtherEpidural

    Patients will have an epidural for pain control

  • OtherPCA

    Patients will have PCA for pain control

06

What researchers measure

Primary outcomes

  1. Length of Hospitalization After Surgery

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

    Time frame: 3-8 days

Secondary outcomes

  1. Operation Time

    Duration of operation in minutes

    Time frame: Duration of operation, an average of 1 hour

  2. Total Operating Room Time

    Total operating room time in minutes

    Time frame: Duration of time in operating room

07

Results

Posted Nov 3, 2020

Participant flow

Participant flow — Overall Study
MilestonePCA Pain ControlEpidural Pain Control
Started3332
Completed3332
Not completed00

Outcome measures

PrimaryLength of Hospitalization After Surgery

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

Time frame:
3-8 days
Reported as:
Mean · hours
Length of Hospitalization After Surgery
hoursPCA Pain ControlEpidural Pain Control
Length of Hospitalization After Surgery111.4 ± 51.4111.3 ± 18.5
SecondaryOperation Time

Duration of operation in minutes

Time frame:
Duration of operation, an average of 1 hour
Reported as:
Mean · minutes
Operation Time
minutesPCA Pain ControlEpidural Pain Control
Operation Time58.9 ± 19.565.3 ± 22.9
SecondaryTotal Operating Room Time

Total operating room time in minutes

Time frame:
Duration of time in operating room
Reported as:
Mean · minutes
Total Operating Room Time
minutesPCA Pain ControlEpidural Pain Control
Total Operating Room Time102.8 ± 26.9127.5 ± 28.4

Adverse events

Collected over From enrollment in trial until follow-up appointment, an average of 2 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PCA Pain Control0/33 (0%)0/33 (0%)0/33 (0%)
Epidural Pain Control0/32 (0%)0/32 (0%)0/32 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)PCA Pain ControlEpidural Pain ControlTotal
Mean14.5 ± 1.315 ± 1.414.75 ± 1.36
Sex: Female, Male
Sex: Female, Male(Participants)PCA Pain ControlEpidural Pain ControlTotal
Female415
Male293160
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)PCA Pain ControlEpidural Pain ControlTotal
Count of participants——0
Height
Height(meters)PCA Pain ControlEpidural Pain ControlTotal
Mean1.8 ± 0.51.7 ± 0.11.75 ± 0.36
Weight
Weight(kg)PCA Pain ControlEpidural Pain ControlTotal
Mean53.9 ± 7.755.9 ± 10.454.88 ± 9.11
Corrective Index
Corrective Index(index score)PCA Pain ControlEpidural Pain ControlTotal
Mean34.9 ± 9.628.6 ± 6.831.80 ± 8.86
08

Study locations

1 site
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01863498
Responsible party
Shawn St. Peter (Professor, Children's Mercy Hospital Kansas City) — Principal investigator
First posted
May 29, 2013
Start date
May 2013
Primary completion
Jan 2018
Completion
Aug 2019
Results posted
Nov 3, 2020
Last update
Nov 3, 2020

Study contacts

Shawn D St. Peter, MD
principal investigator · Children's Mercy Hospital and Clinics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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