Pectus ExcavatumPectusESCNCT05063695
Pectus ESC Outcomes and Comparative Effectiveness Study
An observational study of Pectus Excavatum and Pain, Postoperative, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Investigators hypothesize that Erector spinae catheter pain management protocol would allow patients to have earlier and more effective rehabilitation with decreased length of hospital stay. The aims are to compare LOS between the two groups (epidural and ES groups). Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Pectus Excavatum, Pain, Postoperative
- What is being tested?
- Multimodal Erector spinae catheter protocol
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with pectus excavatum who underwent Nuss procedure
Who may be able to join
- Age>8 years
- Diagnosis of pectus excavatum who underwent Nuss procedure
- Pain regimen included either epidural catheter or ES catheters
Who cannot join
- Developmental delay
- prior pectus repair
- concomitant procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Pragmatic Study Comparing Outcomes of Multimodal Epidural and Erector Spinae Catheter Pain Protocols After Pectus Surgery
Investigators hypothesize that Erector spinae catheter pain management protocol would allow patients to have earlier and more effective rehabilitation with decreased length of hospital stay. The aims are to compare LOS between the two groups (epidural and ES groups). Secondary aims are to compare recovery outcomes (mobilization time), time required to do the blocks, pain scores and opioid use during hospitalization and on follow up after discharge until Pain clinic visit, side effects, family satisfaction and readmissions among the two groups. In addition, in-hospital and post-discharge outcomes in subjects who received ESP protocol will be studied.
Read the detailed description
Retrospective study - Electronic medical records of consecutive patients who underwent pectus surgery between January and December of 2019 (epidural protocol) and those who underwent same procedure between June 2020 to May 2021, will be evaluated. Covariates and outcomes described in sections below will be recorded from EMR. The data included records from flowsheets, pain team notes based on follow up questionnaires administered by phone after discharge until after ESP catheters were removed, as well as pain clinic notes.
- Conditions
- Pectus Excavatum, Pain, Postoperative
- Being tested
- Multimodal Erector spinae catheter protocol
- 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.
Multimodal Erector spinae catheter protocolOther
Also called Multimodal epidural protocol
Patients either received multimodal epidural or ESP protocol
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Patients who underwent Nuss procedure under epidural protocol (between January and December of 2019) | |
| ESP | Patients who underwent Nuss procedure using ESP catheter protocol (June 2020 to April 2021) Receives: Other: Multimodal Erector spinae catheter protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Date of surgery to hospital discharge
Measured: Upto 10 days after surgery
Mobilization
Meeting PT goals
Measured: After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Secondary outcomes (2)
Pain measures
Pain scores postoperative and opioid/benzodiazepine use
Measured: After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Side effects
ED visit, readmission, numbness, infection, LA toxicity etc.
Measured: After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vidya Chidambaran, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063695
- Sponsor's protocol ID
- 2021-0374
- Acronym
- PectusESC
- Status last verified
- Feb 2024
- First submitted
- 17 Sep 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muhly WT, Beltran RJ, Bielsky A, Bryskin RB, Chinn C, Choudhry DK, Cucchiaro G, Fernandez A, Glover CD, Haile DT, Kost-Byerly S, Schnepper GD, Zurakowski D, Agarwal R, Bhalla T, Eisdorfer S, Huang H, Maxwell LG, Thomas JJ, Tjia I, Wilder RT, Cravero JP. Perioperative Management and In-Hospital Outcomes After Minimally Invasive Repair of Pectus Excavatum: A Multicenter Registry Report From the Society for Pediatric Anesthesia Improvement Network. Anesth Analg. 2019 Feb;128(2):315-327. doi: 10.1213/ANE.0000000000003829.
PubMed 30346358Man JY, Gurnaney HG, Dubow SR, DiMaggio TJ, Kroeplin GR, Adzick NS, Muhly WT. A retrospective comparison of thoracic epidural infusion and multimodal analgesia protocol for pain management following the minimally invasive repair of pectus excavatum. Paediatr Anaesth. 2017 Dec;27(12):1227-1234. doi: 10.1111/pan.13264. Epub 2017 Oct 24.
PubMed 29063665Gurria JP, Simpson B, Tuncel-Kara S, Bates C, McKenna E, Rogers T, Kraemer A, Platt M, Mecoli M, Garcia VF, Brown RL. Standardization of clinical care pathway leads to sustained decreased length of stay following Nuss pectus repair: A multidisciplinary quality improvement initiative. J Pediatr Surg. 2020 Dec;55(12):2690-2698. doi: 10.1016/j.jpedsurg.2020.08.009. Epub 2020 Aug 16.
PubMed 32972738Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Study Comparing Outcomes of Multimodal Epidural and Erector Spinae Catheter Pain Protocols After Pectus Surgery
- ClinicalTrials.gov ID
- NCT05063695
- Acronym / sponsor ID
- PectusESC / 2021-0374
- Conditions
- Pectus Excavatum, Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Oct 2021 (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.
Investigators hypothesize that Erector spinae catheter pain management protocol would allow patients to have earlier and more effective rehabilitation with decreased length of hospital stay. The aims are to compare LOS between the two groups (epidural and ES groups). Secondary aims are to compare recovery outcomes (mobilization time), time required to do the blocks, pain scores and opioid use during hospitalization and on follow up after discharge until Pain clinic visit, side effects, family satisfaction and readmissions among the two groups. In addition, in-hospital and post-discharge outcomes in subjects who received ESP protocol will be studied.
Detailed description
Retrospective study - Electronic medical records of consecutive patients who underwent pectus surgery between January and December of 2019 (epidural protocol) and those who underwent same procedure between June 2020 to May 2021, will be evaluated. Covariates and outcomes described in sections below will be recorded from EMR. The data included records from flowsheets, pain team notes based on follow up questionnaires administered by phone after discharge until after ESP catheters were removed, as well as pain clinic notes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | – | –Patients who underwent Nuss procedure under epidural protocol (between January and December of 2019) |
| ESP | – | Other: Multimodal Erector spinae catheter protocolPatients who underwent Nuss procedure using ESP catheter protocol (June 2020 to April 2021) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with pectus excavatum who underwent Nuss procedure
Key inclusion criteria (3 listed)
- Age>8 years
- Diagnosis of pectus excavatum who underwent Nuss procedure
- Pain regimen included either epidural catheter or ES catheters
Key exclusion criteria (3 listed)
- Developmental delay
- prior pectus repair
- concomitant procedures
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 |
|---|---|---|
| Multimodal Erector spinae catheter protocolAlso: Multimodal epidural protocolPatients either received multimodal epidural or ESP protocol | Other | ESP |
Primary outcome
Length of stay
Time frame: Upto 10 days after surgery
Date of surgery to hospital discharge
Mobilization
Time frame: After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Meeting PT goals
2 secondary outcomes
Pain measures
Time frame: After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Side effects
Time frame: After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 30346358Muhly WT, Beltran RJ, Bielsky A, Bryskin RB, Chinn C, Choudhry DK, Cucchiaro G, Fernandez A, Glover CD, Haile DT, Kost-Byerly S, Schnepper GD, Zurakowski D, Agarwal R, Bhalla T, Eisdorfer S, Huang H, Maxwell LG, Thomas JJ, Tjia I, Wilder RT, Cravero JP. Perioperative Management and In-Hospital Outcomes After Minimally Invasive Repair of Pectus Excavatum: A Multicenter Registry Report From the Society for Pediatric Anesthesia Improvement Network. Anesth Analg. 2019 Feb;128(2):315-327. doi: 10.1213/ANE.0000000000003829.
- Background: PubMed 29063665Man JY, Gurnaney HG, Dubow SR, DiMaggio TJ, Kroeplin GR, Adzick NS, Muhly WT. A retrospective comparison of thoracic epidural infusion and multimodal analgesia protocol for pain management following the minimally invasive repair of pectus excavatum. Paediatr Anaesth. 2017 Dec;27(12):1227-1234. doi: 10.1111/pan.13264. Epub 2017 Oct 24.
- Background: PubMed 32972738Gurria JP, Simpson B, Tuncel-Kara S, Bates C, McKenna E, Rogers T, Kraemer A, Platt M, Mecoli M, Garcia VF, Brown RL. Standardization of clinical care pathway leads to sustained decreased length of stay following Nuss pectus repair: A multidisciplinary quality improvement initiative. J Pediatr Surg. 2020 Dec;55(12):2690-2698. doi: 10.1016/j.jpedsurg.2020.08.009. Epub 2020 Aug 16.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Individual participant dataSharing planned: No
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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.
Vidya Chidambaran, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pectus Excavatum and Pain, Postoperative, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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?
Results are not available in the source record.
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: Upto 10 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063695, which also lists 5 linked publications.
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 13 Mar 2024.