Bastianello M, Torre M, Bonfiglio R, Calevo M G, Palomba L, Uva P, Kanapari A, Lorenzoni G, Disma N
Unit for Research in Anaesthesia, IRCCS Istituto Giannina Gaslini, Genova, Italy.
Paediatric Thoracic and Airway Surgery Unit, IRCCS Istituto Giannina Gaslini, Genova, Italy.
Paediatr Anaesth. 2025 May;35(5):347-358. doi: 10.1111/pan.15090. Epub 2025 Mar 4.
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.
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.
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).
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.
NCT05201820.
采用微创方法进行漏斗胸修复手术的患者经常报告术后疼痛严重。本研究的目的是确定与常规护理相比，冷冻镇痛在恢复正常生活质量方面的优越性。
针对接受漏斗胸修复手术的患者设计了一项随机、主动对照、平行组试验（IIb类医疗器械）。参与者从意大利热那亚加斯利尼研究所的择期手术名单中筛选，他们均为学术实践环境的一部分。一旦入选，患者被随机分配到两个研究组之一：冷冻镇痛组与常规护理组（硬膜外镇痛）。主要结局指标是术后14天的儿童生活质量（PedsQL）及其子成分（心理社会和身体健康）。
该方案已获得伦理委员会批准（278/2021-DB编号11421），并于2022年2月至2023年10月期间进行。88名患者参与了本研究：45名接受冷冻镇痛，43名接受硬膜外镇痛。意向性分析显示，术后第14天，冷冻镇痛组和常规护理组的PedsQL中位数（IQR）分别为59.8（48.4，71.2）和67.9（58.7，73.9）（95%CI：0.46 - 13；差值6.5；p = 0.07）；符合方案分析显示，分别为59.8（48.37，71.20）和69.02（58.70，73.91）（95%CI：0.82，14；差值7.4；p = 0.028）。无论采用何种治疗方法，PedsQL总分及其子成分均显著下降。按治疗分层时，这种影响仍然存在：身体健康在两组中均有所下降，而心理社会健康在常规护理组下降更为明显（q值 = 0.028），但在冷冻镇痛组不明显（q值 = 0.056）。
冷冻镇痛并未改善术后2周恢复至基线生活质量的情况。然而，它在PedsQL量表的心理社会成分方面显示出有益作用。
NCT05201820
