An observational study in Pectus Excavatum and Pain, Postoperative, sponsored by Children's Hospital Medical Center, Cincinnati. Active, not recruiting at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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.
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 220 is above the median of 68 across 32 observational studies indexed under Funnel Chest.
Browse Funnel Chest studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient with pectus excavatum who underwent Nuss procedure
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:
Patients who underwent Nuss procedure under epidural protocol (between January and December of 2019)
Patients who underwent Nuss procedure using ESP catheter protocol (June 2020 to April 2021)
Other: Multimodal Erector spinae catheter protocol
Patients either received multimodal epidural or ESP protocol
Also known as: Multimodal epidural protocol
Length of stay
Date of surgery to hospital discharge
Time frame: Upto 10 days after surgery
Mobilization
Meeting PT goals
Time frame: After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Pain measures
Pain scores postoperative and opioid/benzodiazepine use
Time frame: 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.
Time frame: After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Plan to share: No
Started May 2021 (actual). Primary completion is estimated for Dec 2024, 43 months after the start.
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This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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