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

University of Sao Paulo40 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Funnel Chest Pectus Excavatum Postoperative Pain After Video Assisted Thoracic Surgery Postoperative Pain

Interventions

CryotherapyDEVICE

Intraoperative intercostal cryoanalgesia from T3 to T7, billateral

EpiduralPROCEDURE

Thoracic epidural block

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Having pectus excavatum; 2. Having signed the Informed Consent Form for the study. Exclusion Criteria: 1. Age \< 13 years at the time of the procedure; 2. Chronic use of analgesics preoperatively; 3. Pectus carinatum, Poland syndrome, or other chest wall anomalies; 4. Previous pectus excavatum repair by any technique; 5. Previous thoracic surgery; 6. Congenital heart disease; 7. Hemorrhagic dyscrasia; 8. Major anesthetic risk factors or history of previous problems with anesthesia; 9. Pregnancy.

Locations (1)

Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

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

Numeric pain scale

From 0 to 10

Time frame: Perioperative/Periprocedural

Opioid use

Oral Morphine Equivalents (OME)

Time frame: Perioperative/Periprocedural

Postoperative complications

Surgical complications are registered through an specific scale.

Time frame: 30 days post-surgery.

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

Frequency of neuropathic pain

Incidence of chronic neuropathic pain and paresthesia up to 1 year post-surgery in the group undergoing intercostal cryoablation, using LANNS (Leeds assessment of Neuropathic Symptoms and Signs) scale.

Time frame: Up to 1 year post-surgery.

Satisfaction with the post-operative result

Compare patient-reported experience measures (PREMs) between the intercostal cryoablation and thoracic epidural block groups based on postoperative satisfaction at 6 months, assessed using the Single Step Questionnaire (SSQ) score.

Time frame: Single evaluation during the outpatient follow-up 6 months after surgery.

Central Contacts

Miguel L Tedde, MD, PhD

CONTACT

55-11-99653-5030 tedde@usp.br

Diego Arley G Silva, MD

CONTACT

55-83-98650-6438 diegoarley@usp.br

Data from ClinicalTrials.gov

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