Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Memorial Health Institute, Poland

About this trial

Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications.

This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pectus excavatum repair with MIRPE

Written consent for corrective surgery with intraoperative cryoanalgesia

Written consent to participate in the study

Age >12 and < 18 years

Disqualifiers

History of previous thoracic surgeries

Reoperation for chest deformity

Contraindication for cryoanalgesia

Presence of other conditions that may affect the course of the procedures and the assessment of their effectiveness and safety

Trial design

Design model

Parallel

Treatments tested in this trial

  • One minute intercostal nerves cryoanalgesia

    Procedure/Surgery

    One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7

  • Two minutes intercostal nerves cryoanalgesia

    Procedure/Surgery

    Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: One minute cryoanalgesiaExperimental treatment 1 intervention
Group B: Two minutes cryoanalgesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain level according to Numerical Rating Scale (NRS)

Time frame
1 week

Secondary outcomes

1

Opioid consumption

Time frame
1 week
2

Duration of the surgery

Time frame
1 day
3

Length of postoperative hospital stay

Time frame
1 week
4

Occurence of early complications

Time frame
30 days from the surgery

Other outcomes

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