The Optimization of the Intercostal Nerves Cryoablation Aplication Time During Nuss Procedure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- The worse pain occurrence during first 24 hours after operation.
Study Overview
Brief Summary
This study compared standard therapy (multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in subject undergoing minimal invasive modyfied Nuss procedure with thoracoscopy.
Detailed Description
Funnel chest deformation may be a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain.
2 minutes per one intercostal nerve aplication cryoanalgesia as a part of multimodal analgesia is a standard protocol in many countries.
This Prospective Non-Randomized Study is a single institution pilot study designed to compare standard therapy (control side: multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in each patient to address the need for better management of acute and long-term pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method.
All of the patients will receive a standard care according to Polish guidelines: multimodal analgesia with regional analgesia (bilateral erector spine plane block) with cryoanalgesia. The right intercostal nerves will be treated with 2 minutes cryoanalgesia (control side). The left side of the chest (left intercostal nerves) will be treated with 1 minute cryoanalgesia (intervention side).
The intraoperative cryoanalgesia will be performed using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique
- •informed concent signed for cryolesia
Exclusion Criteria
- •age 9 years or below
- •refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief
Outcomes
Primary Outcomes
The worse pain occurrence during first 24 hours after operation.
Time Frame: up to 24 hours after operation
numeric pain score, range from 0 to 10
Secondary Outcomes
- residual wound or chest pain occurrence(postoperative months 1,3)
- thoracic hypoaesthesia occurrence(up to 24 hours after operation)
- duration of hospitalization(estimated 4 days)