Trial reportPaediatric anaesthesia2025
Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial.
Trial report in Paediatric anaesthesia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05201820 (Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial
Who cites it
1 citing paper in PubMed.
- Overcoming anatomical prohibition: Cross-bar Nuss elevation as a gateway to minimally invasive mitral valve repair.JTCVS techniques · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundPatients undergoing Pectus Excavatum repair with the minimally invasive approach frequently report severe postoperative pain. The goal of the study is to determine the superiority of cryoanalgesia compared to standard of care for return to normal quality of life.
methodsA randomized, active controlled, parallel groups trial (category IIb medical device) was designed for patients undergoing pectus excavatum repair. Participants were screened from the elective surgical lists at Istituto Gaslini, Genova, Italy, and they all were part of the academic practice setting. Once enrolled, patients were randomly assigned to one of the two study arms: cryoanalgesia vs. standard of care (epidural-based analgesia). The primary outcome was the Pediatric Quality of Life (PedsQL) and the subcomponents (psychosocial and physical health) 14 days after surgery.
resultsProtocol was approved by the Ethics Committee (278/2021-DB id 11 421) and conducted between February 2022 and October 2023. Eighty-eight patients were enrolled in the study: forty-five to cryoanalgesia and forty-three in the epidural arm. The PedsQL median (IQR) at the 14th day was 59.8 (48.4, 71.2) vs. 67.9 (58.7, 73.9) (95% CI: 0.46-13; difference 6.5; p = 0.07) with ITT analysis, and 59.8 (48.37, 71.20) vs. 69.02 (58.70, 73.91) (95% CI: 0.82, 14; difference 7.4; p = 0.028) with PP analysis, in the cryoanalgesia and in the standard of care group, respectively. Irrespective of treatment, a significant decrease in both the PedsQL total score and its subcomponents was found. This effect persisted when stratified by treatment: physical health showed a decrease in both arms, while psychosocial health demonstrated a more marked decrease in the standard of care arm (q-value = 0.028), but not in the cryoanalgesia arm (q-value = 0.056).
conclusionsCryoanalgesia did not improve return to baseline quality of life 2 weeks after surgery. However, it showed to be beneficial in the psychosocial component of the PedsQL scale.
trial registrationNCT05201820.
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