Pectus ESC Outcomes and Comparative Effectiveness Study

Pain, Postoperative Clinical Trial

— PectusESC  

Official title:

Pragmatic Study Comparing Outcomes of Multimodal Epidural and Erector Spinae Catheter Pain Protocols After Pectus Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05063695
• Other study ID #: 2021-0374
• Status: Active, not recruiting
• Start date: May 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Age>8 years

• Diagnosis of pectus excavatum who underwent Nuss procedure

• Pain regimen included either epidural catheter or ES catheters

Exclusion Criteria:

• Developmental delay

• prior pectus repair

• concomitant procedures

Related Conditions & MeSH terms

• Funnel Chest
• Pain, Postoperative
• Pectus Excavatum

Intervention

Other:
• Multimodal Erector spinae catheter protocol
Patients either received multimodal epidural or ESP protocol

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (5)

Forero 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. — View Citation

Gurria 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. — View Citation

Man 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. — View Citation

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. — View Citation

Tsui 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Date of surgery to hospital discharge	Upto 10 days after surgery
Primary	Mobilization	Meeting PT goals	After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Secondary	Pain measures	Pain scores postoperative and opioid/benzodiazepine use	After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)
Secondary	Side effects	ED visit, readmission, numbness, infection, LA toxicity etc.	After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)