Pectus ESC Outcomes and Comparative Effectiveness Study

NCT05063695 | Active Not Recruiting

• 1 other identifier: 2021-0374
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pectus Excavatum; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• Length of stay

  Date of surgery to hospital discharge

  Upto 10 days after surgery

• 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 Outcomes (2)

• Pain measures

  After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)

• Side effects

  After surgery in-hospital, phone calls until POD6, pain clinic and surgery clinic postop visit (within 4 weeks after surgery)

Study Arms (2)

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)

Other: Multimodal Erector spinae catheter protocol

Interventions

Multimodal Erector spinae catheter protocol OTHER

Patients either received multimodal epidural or ESP protocol

Also known as: Multimodal epidural protocol

ESP

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with pectus excavatum who underwent Nuss procedure

You may qualify if:

• Age\>8 years
• Diagnosis of pectus excavatum who underwent Nuss procedure
• Pain regimen included either epidural catheter or ES catheters

You may not qualify if:

• Developmental delay
• prior pectus repair
• concomitant procedures

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (5)

• 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.

  PMID: 30346358 BACKGROUND

• 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.

  PMID: 29063665 BACKGROUND

• 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.

  PMID: 32972738 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 30292068 BACKGROUND

MeSH Terms

Conditions

Funnel Chest; Pain, Postoperative

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Vidya Chidambaran, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 1, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)