Comparing one-minute and two-minute cryoanalgesia for pain management in Nuss surgery
Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery: A Pilot Randomized Controlled Trial
NA · Children's Memorial Health Institute, Poland · NCT06935799
This study is testing whether using cryoanalgesia for one minute instead of two minutes can help reduce pain after Nuss surgery for people with pectus excavatum.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Memorial Health Institute, Poland (other) |
| Locations | 1 site (Warsaw, Wybierz Województwo) |
| Trial ID | NCT06935799 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of one-minute versus two-minute cryoanalgesia for managing postoperative pain in patients undergoing the Nuss procedure for pectus excavatum. It is a randomized, double-blind trial conducted at a single center, focusing on evaluating pain intensity, opioid consumption, surgery duration, hospital stay length, and complications. The study aims to determine the optimal duration of cryoanalgesia, as current protocols predominantly use two minutes despite evidence suggesting one minute may be equally effective.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 18 years undergoing pectus excavatum repair with minimally invasive techniques.
Not a fit: Patients with a history of previous thoracic surgeries or contraindications for cryoanalgesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing Nuss surgery, potentially reducing opioid use and enhancing recovery.
How similar studies have performed: While the approach of cryoanalgesia has shown promise in pain management, this specific comparison of durations is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Warsaw, Wybierz Województwo
- The Children's Memorial Health Institute — Warsaw, Wybierz Województwo, Poland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pectus Excavatum, Funnel Chest, cryoanalgesia, pain management, pectus excavatum, funnel chest