Pectus Excavatum(MIRPE)NCT04211935
Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum
A study testing Use of PCA in people with Pectus Excavatum and Pain, Postoperative, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum, Pain, Postoperative
- What is being tested?
- Use of PCA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients with a pectus excavatum deformity that will undergo a MIRPE procedure will be included in the study.
Who cannot join
- < 12 years old
- > 21 years old
- chronic narcotic preoperative use
- previous repair of pectus excavatum deformity
- previous thoracic surgery
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: The Use of Video-assisted Intercostal Nerve Cryoablation, Erector Spinae Block, and Thoracic Epidural for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum
Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usually performed in the teenage years. A common operative procedure to repair a pectus deformity is the minimally invasive repair of pectus excavatum (MIRPE). The MIRPE involves the substernal placement of a contoured metal bar secured to the lateral aspect of the ribs. This metal bar allows for correction of the concave deformity by applying constant outward pressure to the underside of the sternum. Although the cosmetic results are excellent, patients do report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches tend to differ on both the provider and institutional level. There is a lack of evidence regarding which postoperative analgesia method is best. To address this research gap, this proposal aims to conduct a randomized controlled trail using the three most commonly used methods; 1) patient controlled analgesia (PCA); 2) erector spinae blocks (ESB) with continuous infusion pumps; and 3) video-assisted intercostal nerve cryoablation (INC).
Read the detailed description
Pectus excavatum deformity is a common condition in a pediatric surgical practice. While MIRPE provides excellent cosmetic results and is associated with shorter operative time and lower intraoperative blood loss, the immediate correction of the concave deformity with a metal bar places patients in a difficult pain control situation. While multiple postoperative analgesia modalities have been studied, there is still a need for a large, prospective, randomized trial that is appropriately powered to evaluate the best pain control modality after MIRPE. Of the clinically appropriate interventions, ESB and INC have been shown to have comparable LOS after the operation, especially when employed as part of an enhanced recovery pathway (ERP) bundle. Comparing these newer analgesia modalities to the more established PCA approach may help identify the most effective postoperative pain control approach that maximizes the safety profile while minimizing the use of narcotic pain medications after MIRPE.
The investigators propose a prospective randomized trial evaluating the effectiveness of INC, PCA and ESB with continuous local anesthetic infusion via a pain pump delivery system. All groups will follow a multimodal enhanced recovery pathway. Groups will different only in the use of INC, PCA, or ESB.
Since previous studies have reported similarly short LOS for both ESB and INC, but no prospective, direct comparisons of these techniques have been done, we believe comparing these two groups to the more established PCA modality will further advance the field of post MIRPE pain management by providing precise estimates of length of stay (LOS), hospital resource utilization, and other important outcomes that have not received sufficient attention including pain, quality of life, resumption of activities of daily living, and a rigorous survey for potential adverse outcomes. The investigators specifically hypothesize that because of the long-term analgesia of up to 2-3 months, the INC group may experience not only shorter LOS but decreased narcotic use than the ESB and PCA groups, and also improved quality of life, with fewer encounters in the postoperative period (30 days) for pain related concerns.
- Conditions
- Pectus Excavatum, Pain, Postoperative
- Being tested
- Use of PCA, Use of ESB for postoperative pain control after MIRPE, Use of INC for postoperative pain control after MIRPE
- Medical subject headings
- Funnel Chest, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of PCADevice
A commercially available PCA pump will be connected to the patient's intravenous line at the end of the MIRPE operation.
Use of ESB for postoperative pain control after MIRPEDevice
Pediatric anesthesiologists will place ESB at the time of the MIRPE operation if study participants are randomized into this group.
Use of INC for postoperative pain control after MIRPEDevice
Pediatric surgeons will perform INC during the MIRPE operation if they are randomized to this group.
| Study group | Role | What they receive |
|---|---|---|
| Patient Controlled Analgesia | Experimental | This technique involves connecting a patient controlled analgesia pump to the intravenous line. The patient has the ability to push a button to obtain a predetermined dose of an intravenous opioid with a set lockout time period to minimize the potential for over sedation. PCA pumps will be connected to the intravenous line of the patient at the end of the MIRPE operation. anesthesiologists with experience in regional anesthesia. Receives: Device: Use of PCA |
| Erector Spinae Block | Experimental | This method consists of the anesthesiologist placing two catheters on each side of the vertebrae which then delivers pain medicine continuously via pumps for 2-3 days post-surgery. Receives: Device: Use of ESB for postoperative pain control after MIRPE |
| Intercostal Nerve Cryoablation | Experimental | The INC technique relies on multilevel freezing of the intercostal neurovascular bundle intraoperatively to block sensation and pain for approximately 2 months postoperatively. Trained pediatric surgeons will perform the INC at the time of a MIRPE procedure. Receives: Device: Use of INC for postoperative pain control after MIRPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
The investigators will measure the total length of stay following the operation until discharge from the hospital.
Measured: 24 months
Secondary outcomes (4)
Total intravenous and oral opioid use
The investigators will quantify the total opioid usage during the hospitalization and also at home and will convert the total results to morphine equivalences for standardization.
Measured: 24 months
Postoperative pain
The investigators will use reported pain scores to quantify this measure. Scale of 0-10 (0=no pain, 10=worst pain experienced). The investigators will also ask about chest numbness for those in the INC group and will report it on a 0-100% scale (0%=no numbness at all, 100%=completely numb or absent of any sensation).
Measured: 24 months
Quality of life after MIRPE
The investigators will use a questionnaire to identify if patients are back to baseline and performing their activities of daily living. The investigators will also ask about resumption of any sports related activities after the appropriate postoperative restriction timeframe has passed. This will be a multiple choice questionnaire that will record if 1) they are back to baseline, 2) they are almost back to baseline, 3) they are not back to baseline at all. The investigators will also ask in a multiple choice manner if they have resumed their activities of daily living. The possible answers will be 1) Yes, 2) Incorporating some of the preoperative activities, 3) No
Measured: 24 months
Complications
The investigators will ask patients about postoperative complications when they are at home. We will also refer back to the chart for any complications that occur during the initial postoperative period or those that have required a readmission after the initial operation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start27 May 2020
- Primary completion25 Feb 2026
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Natasha Corbitt, MD, Study director, Safety Officer--University of Texas Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211935
- Sponsor's protocol ID
- 19-2794
- Acronym
- (MIRPE)
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2019
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Video-assisted Intercostal Nerve Cryoablation, Erector Spinae Block, and Thoracic Epidural for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum
- ClinicalTrials.gov ID
- NCT04211935
- Acronym / sponsor ID
- (MIRPE) / 19-2794
- Conditions
- Pectus Excavatum, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 27 May 2020 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usually performed in the teenage years. A common operative procedure to repair a pectus deformity is the minimally invasive repair of pectus excavatum (MIRPE). The MIRPE involves the substernal placement of a contoured metal bar secured to the lateral aspect of the ribs. This metal bar allows for correction of the concave deformity by applying constant outward pressure to the underside of the sternum. Although the cosmetic results are excellent, patients do report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches tend to differ on both the provider and institutional level. There is a lack of evidence regarding which postoperative analgesia method is best. To address this research gap, this proposal aims to conduct a randomized controlled trail using the three most commonly used methods; 1) patient controlled analgesia (PCA); 2) erector spinae blocks (ESB) with continuous infusion pumps; and 3) video-assisted intercostal nerve cryoablation (INC).
Detailed description
Pectus excavatum deformity is a common condition in a pediatric surgical practice. While MIRPE provides excellent cosmetic results and is associated with shorter operative time and lower intraoperative blood loss, the immediate correction of the concave deformity with a metal bar places patients in a difficult pain control situation. While multiple postoperative analgesia modalities have been studied, there is still a need for a large, prospective, randomized trial that is appropriately powered to evaluate the best pain control modality after MIRPE. Of the clinically appropriate interventions, ESB and INC have been shown to have comparable LOS after the operation, especially when employed as part of an enhanced recovery pathway (ERP) bundle. Comparing these newer analgesia modalities to the more established PCA approach may help identify the most effective postoperative pain control approach that maximizes the safety profile while minimizing the use of narcotic pain medications after MIRPE.
The investigators propose a prospective randomized trial evaluating the effectiveness of INC, PCA and ESB with continuous local anesthetic infusion via a pain pump delivery system. All groups will follow a multimodal enhanced recovery pathway. Groups will different only in the use of INC, PCA, or ESB.
Since previous studies have reported similarly short LOS for both ESB and INC, but no prospective, direct comparisons of these techniques have been done, we believe comparing these two groups to the more established PCA modality will further advance the field of post MIRPE pain management by providing precise estimates of length of stay (LOS), hospital resource utilization, and other important outcomes that have not received sufficient attention including pain, quality of life, resumption of activities of daily living, and a rigorous survey for potential adverse outcomes. The investigators specifically hypothesize that because of the long-term analgesia of up to 2-3 months, the INC group may experience not only shorter LOS but decreased narcotic use than the ESB and PCA groups, and also improved quality of life, with fewer encounters in the postoperative period (30 days) for pain related concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Controlled Analgesia | Experimental | Device: Use of PCAThis technique involves connecting a patient controlled analgesia pump to the intravenous line. The patient has the ability to push a button to obtain a predetermined dose of an intravenous opioid with a set lockout time period to minimize the potential for over sedation. PCA pumps will be connected to the intravenous line of the patient at the end of the MIRPE operation. anesthesiologists with experience in regional anesthesia. |
| Erector Spinae Block | Experimental | Device: Use of ESB for postoperative pain control after MIRPEThis method consists of the anesthesiologist placing two catheters on each side of the vertebrae which then delivers pain medicine continuously via pumps for 2-3 days post-surgery. |
| Intercostal Nerve Cryoablation | Experimental | Device: Use of INC for postoperative pain control after MIRPEThe INC technique relies on multilevel freezing of the intercostal neurovascular bundle intraoperatively to block sensation and pain for approximately 2 months postoperatively. Trained pediatric surgeons will perform the INC at the time of a MIRPE procedure. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients with a pectus excavatum deformity that will undergo a MIRPE procedure will be included in the study.
Key exclusion criteria (6 listed)
- < 12 years old
- > 21 years old
- chronic narcotic preoperative use
- previous repair of pectus excavatum deformity
- previous thoracic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of PCAA commercially available PCA pump will be connected to the patient's intravenous line at the end of the MIRPE operation. | Device | Patient Controlled Analgesia |
| Use of ESB for postoperative pain control after MIRPEPediatric anesthesiologists will place ESB at the time of the MIRPE operation if study participants are randomized into this group. | Device | Erector Spinae Block |
| Use of INC for postoperative pain control after MIRPEPediatric surgeons will perform INC during the MIRPE operation if they are randomized to this group. | Device | Intercostal Nerve Cryoablation |
Primary outcome
Length of Stay
Time frame: 24 months
The investigators will measure the total length of stay following the operation until discharge from the hospital.
4 secondary outcomes
Total intravenous and oral opioid use
Time frame: 24 months
Postoperative pain
Time frame: 24 months
Quality of life after MIRPE
Time frame: 24 months
Complications
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Pectus Excavatum
RecruitingObservational study
Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain
Juvenile Idiopathic Arthritis (JIA), Fibromyalgia
Active, not recruiting
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Pain, Postoperative, Excavatum, Pectus
Active, not recruitingObservational study
Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Scoliosis, Kyphosis
Recruiting
ES Catheter vs Cryoablation After Pectus Surgery
Pectus Excavatum
Active, not recruiting
Pectus Excavatum Camouflage (IT)
Pectus Excavatum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Corbitt, MD study director
Safety Officer--University of Texas Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of PCA in people with Pectus Excavatum and Pain, Postoperative, run by University of Colorado, Denver 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Stay (time frame: 24 months). 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 28 Apr 2026.