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Recruiting NCT07431632

Intraoperative Cryoanalgesia Versus Thoracic Epidural Block in MIRPE (Minimally Invasive Repair of Pectus Excavatum)

No phase Interventional Funnel Chest Pectus Excavatum Postoperative Pain After Video Assisted Thoracic Surgery Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryotherapy, Epidural.
Who it may be relevant to
Registry conditions: Funnel Chest, Pectus Excavatum, Postoperative Pain After Video Assisted Thoracic Surgery, Postoperative Pain. Basic parameters: from 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparative Study of the Efficacy of Intraoperative Intercostal Cryoanalgesia and Thoracic Epidural Block in the Postoperative Period of Minimally Invasive Pectus Excavatum Repair (MIRPE): a Prospective, Randomized Clinical Trial

Overview

The main objective of this study is to compare epidural blockade with cryoanalgesia of the intercostal nerves as an analgesic method in the postoperative period of minimally invasive repair of pectus excavatum (MIRPE).

Interventions

  • Device Cryotherapy
    Intraoperative intercostal cryoanalgesia from T3 to T7, billateral
  • Procedure Epidural
    Thoracic epidural block

Primary outcome measures

  • Length of stay (LOS) [Time frame: Perioperative/Periprocedural.]
Secondary outcome measures (7)
  • Numeric pain scale [Time frame: Perioperative/Periprocedural]
  • Opioid use [Time frame: Perioperative/Periprocedural]
  • Postoperative complications [Time frame: 30 days post-surgery.]
  • Readmissions to the emergency room or hospital readmission [Time frame: Within 30 days after surgery]
  • Frequency of neuropathic pain [Time frame: Up to 1 year post-surgery.]
  • Satisfaction with the post-operative result [Time frame: Single evaluation during the outpatient follow-up 6 months after surgery.]
  • Cost of hospitalization (in Brazilian Real) [Time frame: Perioperative/Periprocedural]

Eligibility criteria

Inclusion criteria

  • Having pectus excavatum;
  • Having signed the Informed Consent Form for the study.

Exclusion criteria

  • Age < 13 years at the time of the procedure;
  • Chronic use of analgesics preoperatively;
  • Pectus carinatum, Poland syndrome, or other chest wall anomalies;
  • Previous pectus excavatum repair by any technique;
  • Previous thoracic surgery;
  • Congenital heart disease;
  • Hemorrhagic dyscrasia;
  • Major anesthetic risk factors or history of previous problems with anesthesia;
  • Pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School — São Paulo

Identifiers

NCT: NCT07431632 · 83154924.6.0000.0068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗