NCT06682208

Brief Summary

Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups:

  • Time to achieve short-term physical therapy goals and long-term functional outcomes
  • Compare immediate and long-term postoperative opioid use
  • Compare numbness on chest of postoperative day 1 and the return of sensation to baseline
  • Compare the incidence of neuropathic pain and other complications Participants will receive surveys for up to 12 months postoperatively.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Apr 2024Apr 2029

Study Start

First participant enrolled

April 8, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

November 7, 2024

Last Update Submit

September 17, 2025

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

  • Compare time to reach discharge

    Comparing physical therapy goals to meet discharge criteria.

    Day of surgery up tp 10 days post-operative

Secondary Outcomes (3)

  • Opioid consumption

    Day of surgery to up to one year

  • Numbness on chest

    Day of surgery and post-operative day 1

  • Neuropathic pain

    Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operatively

Study Arms (2)

ES Catheter

ACTIVE COMPARATOR

Hospital procedure for ES catheters will be followed for postoperative pain.

Procedure: ES catheter

Intercostal Nerve Cryoablation (INC)

ACTIVE COMPARATOR

Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.

Procedure: Intercostal nerve cryoablation (INC)

Interventions

ES catheterPROCEDURE

ES catheter for postoperative pain control

ES Catheter
Intercostal nerve cryoablation (INC)PROCEDURE

INC used for postoperative pain control

Intercostal Nerve Cryoablation (INC)

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12 - 21 years
  • History of pectus excavatum
  • Scheduled for Nuss procedure

You may not qualify if:

  • Prior pectus repair
  • Other concomitant surgeries
  • Chronic pain conditions including Ehlers Danlos Syndrome
  • Non-English speaking - rationale: the questionnaires used in the study are in English language and the social and cultural factors of pain perception of non-English speaking patients could affect the study power
  • Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficulties communicating)
  • History of or active renal or liver disease
  • Major surgery requiring opioids in the last 2 years
  • Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
  • Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, uncontrolled hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included
  • BMI \>35
  • Pregnant or breastfeeding females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Charlotte Walter, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Surya Narayanasamy, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Walter, MD

CONTACT

513-636-4408Charlotte.Walter@cchmc.org

Kristie Geisler, BS

CONTACT

513-636-3282Kristie.geisler@cchmc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 12, 2024

Study Start

April 8, 2024

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations

US(1)