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

ConditionsFunnel ChestPectus ExcavatumPostoperative Pain After Video Assisted Thoracic SurgeryPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorUniversity of Sao Paulo

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Having pectus excavatum;

Having signed the Informed Consent Form for the study.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cryotherapy

    Device

    Intraoperative intercostal cryoanalgesia from T3 to T7, billateral

  • Epidural

    Procedure/Surgery

    Thoracic epidural block

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intraoperative intercostal cryoanalgesiaExperimental treatment 1 intervention
Group B: Thoracic epidural blockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of stay (LOS)

Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital.

Time frame
Perioperative/Periprocedural.

Secondary outcomes

1

Numeric pain scale

From 0 to 10

Time frame
Perioperative/Periprocedural
2

Opioid use

Oral Morphine Equivalents (OME)

Time frame
Perioperative/Periprocedural
3

Postoperative complications

Surgical complications are registered through an specific scale.

Time frame
30 days post-surgery.
4

Readmissions to the emergency room or hospital readmission

Compare the frequency and reason for readmissions to the emergency room or hospital admission between groups.

Time frame
Within 30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Source ClinicalTrials.gov
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