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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01863498
Acronym
PectusEpiPCA
Enrollment
65
Registered
2013-05-29
Start date
2013-05-31
Completion date
2019-08-31
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pectus Excavatum

Keywords

pectus excavatum, pain control

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.

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.

Interventions

OTHEREpidural

Patients will have an epidural for pain control

OTHERPCA

Patients will have PCA for pain control

Sponsors

Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Length of Hospitalization After Surgery3-8 daysThe primary outcome variable is length of hospitalization after the intervention.

Secondary

MeasureTime frameDescription
Operation TimeDuration of operation, an average of 1 hourDuration of operation in minutes
Total Operating Room TimeDuration of time in operating roomTotal operating room time in minutes

Countries

United States

Participant flow

Participants by arm

ArmCount
PCA Pain Control
Patients will have PCA for pain control PCA: Patients will have PCA for pain control
33
Epidural Pain Control
Patients will have an epidural for pain control Epidural: Patients will have an epidural for pain control
32
Total65

Baseline characteristics

CharacteristicPCA Pain ControlEpidural Pain ControlTotal
Age, Continuous14.5 years
STANDARD_DEVIATION 1.3
15 years
STANDARD_DEVIATION 1.4
14.75 years
STANDARD_DEVIATION 1.36
Corrective Index34.9 index score
STANDARD_DEVIATION 9.6
28.6 index score
STANDARD_DEVIATION 6.8
31.80 index score
STANDARD_DEVIATION 8.86
Height1.8 meters
STANDARD_DEVIATION 0.5
1.7 meters
STANDARD_DEVIATION 0.1
1.75 meters
STANDARD_DEVIATION 0.36
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
4 Participants1 Participants5 Participants
Sex: Female, Male
Male
29 Participants31 Participants60 Participants
Weight53.9 kg
STANDARD_DEVIATION 7.7
55.9 kg
STANDARD_DEVIATION 10.4
54.88 kg
STANDARD_DEVIATION 9.11

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 330 / 32
other
Total, other adverse events
0 / 330 / 32
serious
Total, serious adverse events
0 / 330 / 32

Outcome results

Primary

Length of Hospitalization After Surgery

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

Time frame: 3-8 days

ArmMeasureValue (MEAN)Dispersion
PCA Pain ControlLength of Hospitalization After Surgery111.4 hoursStandard Deviation 51.4
Epidural Pain ControlLength of Hospitalization After Surgery111.3 hoursStandard Deviation 18.5
Secondary

Operation Time

Duration of operation in minutes

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

ArmMeasureValue (MEAN)Dispersion
PCA Pain ControlOperation Time58.9 minutesStandard Deviation 19.5
Epidural Pain ControlOperation Time65.3 minutesStandard Deviation 22.9
Secondary

Total Operating Room Time

Total operating room time in minutes

Time frame: Duration of time in operating room

ArmMeasureValue (MEAN)Dispersion
PCA Pain ControlTotal Operating Room Time102.8 minutesStandard Deviation 26.9
Epidural Pain ControlTotal Operating Room Time127.5 minutesStandard Deviation 28.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026