M Bastianello, M Torre, R Bonfiglio, M G Calevo, L Palomba, P Uva, A Kanapari, G Lorenzoni, N Disma
{"title":"低温镇痛在青少年漏斗胸修复（铜）后疼痛管理：一项随机对照试验。","authors":"M Bastianello, M Torre, R Bonfiglio, M G Calevo, L Palomba, P Uva, A Kanapari, G Lorenzoni, N Disma","doi":"10.1111/pan.15090","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients 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.</p><p><strong>Methods: </strong>A 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.</p><p><strong>Results: </strong>Protocol 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).</p><p><strong>Conclusions: </strong>Cryoanalgesia 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.</p><p><strong>Trial registration: </strong>NCT05201820.</p>","PeriodicalId":19745,"journal":{"name":"Pediatric Anesthesia","volume":" ","pages":"347-358"},"PeriodicalIF":1.7000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11975181/pdf/","citationCount":"0","resultStr":"{\"title\":\"Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial.\",\"authors\":\"M Bastianello, M Torre, R Bonfiglio, M G Calevo, L Palomba, P Uva, A Kanapari, G Lorenzoni, N Disma\",\"doi\":\"10.1111/pan.15090\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients 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.</p><p><strong>Methods: </strong>A 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.</p><p><strong>Results: </strong>Protocol 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).</p><p><strong>Conclusions: </strong>Cryoanalgesia did not improve return to baseline quality of life 2 weeks after surgery. 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Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial.
Background: Patients 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.
Methods: A 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.
Results: Protocol 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).
Conclusions: Cryoanalgesia 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.
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Devoted to the dissemination of research of interest and importance to practising anesthetists everywhere, the scientific and clinical content of Pediatric Anesthesia covers a wide selection of medical disciplines in all areas relevant to paediatric anaesthesia, pain management and peri-operative medicine. The International Editorial Board is supported by the Editorial Advisory Board and a team of Senior Advisors, to ensure that the journal is publishing the best work from the front line of research in the field. The journal publishes high-quality, relevant scientific and clinical research papers, reviews, commentaries, pro-con debates, historical vignettes, correspondence, case presentations and book reviews.
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