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
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.
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.
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will have PCA for pain control
Other: PCA
Patients will have an epidural for pain control
Other: Epidural
Patients will have an epidural for pain control
Patients will have PCA for pain control
Length of Hospitalization After Surgery
The primary outcome variable is length of hospitalization after the intervention.
Time frame: 3-8 days
Operation Time
Duration of operation in minutes
Time frame: Duration of operation, an average of 1 hour
Total Operating Room Time
Total operating room time in minutes
Time frame: Duration of time in operating room
| Milestone | PCA Pain Control | Epidural Pain Control |
|---|---|---|
| Started | 33 | 32 |
| Completed | 33 | 32 |
| Not completed | 0 | 0 |
The primary outcome variable is length of hospitalization after the intervention.
| hours | PCA Pain Control | Epidural Pain Control |
|---|---|---|
| Length of Hospitalization After Surgery | 111.4 ± 51.4 | 111.3 ± 18.5 |
Duration of operation in minutes
| minutes | PCA Pain Control | Epidural Pain Control |
|---|---|---|
| Operation Time | 58.9 ± 19.5 | 65.3 ± 22.9 |
Total operating room time in minutes
| minutes | PCA Pain Control | Epidural Pain Control |
|---|---|---|
| Total Operating Room Time | 102.8 ± 26.9 | 127.5 ± 28.4 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PCA Pain Control | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Epidural Pain Control | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | PCA Pain Control | Epidural Pain Control | Total |
|---|---|---|---|
| Mean | 14.5 ± 1.3 | 15 ± 1.4 | 14.75 ± 1.36 |
| Sex: Female, Male(Participants) | PCA Pain Control | Epidural Pain Control | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 29 | 31 | 60 |
| Race and Ethnicity Not Collected(Participants) | PCA Pain Control | Epidural Pain Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Height(meters) | PCA Pain Control | Epidural Pain Control | Total |
|---|---|---|---|
| Mean | 1.8 ± 0.5 | 1.7 ± 0.1 | 1.75 ± 0.36 |
| Weight(kg) | PCA Pain Control | Epidural Pain Control | Total |
|---|---|---|---|
| Mean | 53.9 ± 7.7 | 55.9 ± 10.4 | 54.88 ± 9.11 |
| Corrective Index(index score) | PCA Pain Control | Epidural Pain Control | Total |
|---|---|---|---|
| Mean | 34.9 ± 9.6 | 28.6 ± 6.8 | 31.80 ± 8.86 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Mercy Hospital Kansas City →