Background/Objectives: Our objective was to evaluate the clinical feasibility and sustainability of an awake breast conserving surgery (BCS) protocol integrating opioid-free anesthesia, telemedicine, and environmental sustainability compared to standard care. Methods: A prospective, monocentric, non-inferiority randomized controlled trial (133.24 CET2 ptv; NCT06624917) named Breast Green Surgery (BuGS) was planned. Women aged 18–75 years eligible for level I BCS were randomized to either the BuGS group—comprising opioid-free monitored anesthesia care (MAC), a telehealth follow-up, and intraoperative waste reduction—or the control. The primary endpoint was postoperative pain at rest (PPR) and during movement (PPD) both at 24 h, measured with the Numeric Pain Rating Scale (NPRS). Secondary exploratory endpoints included SF-36, PSQ-18, TSQ test, LOS, and KgCO2 equivalent (KgCO2e) from surgical waste, patient transport, and complications. The interim analysis included patients completing a 30-day follow-up by 31 December 2024. Results: A total of 45 patients were enrolled (BuGS n = 18, control n = 27). While disproportionate, no significant differences were observed in PPR/PPD at 24 h (4.75 (3.725–5.875) vs. 4.5 (4.15–5.35); p = 0.626; 4 (3.10–4.75) vs. 4.6 (3.90–5.2); p = 0.130), confirmed using group ANOVA analysis (p = 0.515; p = 0.779, respectively). The BuGS group reported a reduced surgical room occupation (80.03 (64.84–101.87) vs. 133.23 (95.47–144.25) min; p = 0.002) and length of stay (0 (0–1) vs. 1 (1–2); p = 0.0001), without hospital unplanned admissions. Reduced KgCO2e emissions from waste disposal were reported, with no difference in SF-36, PSQ-18, and complication rates. Conclusions: If confirmed after complete accrual, BuGS could potentially promote a clinically equivalent, environmentally sustainable, and hospital efficient surgery without affecting the QoL of our patients. Further multicentric validation is warranted.
Feasibility of a Green Breast Surgery Protocol to Reduce Carbon Footprint of Care: BuGS Trial Interim Results
Di Mauro, Giordana;Berretta, MassimilianoPenultimo
Membro del Collaboration Group
;
2025-01-01
Abstract
Background/Objectives: Our objective was to evaluate the clinical feasibility and sustainability of an awake breast conserving surgery (BCS) protocol integrating opioid-free anesthesia, telemedicine, and environmental sustainability compared to standard care. Methods: A prospective, monocentric, non-inferiority randomized controlled trial (133.24 CET2 ptv; NCT06624917) named Breast Green Surgery (BuGS) was planned. Women aged 18–75 years eligible for level I BCS were randomized to either the BuGS group—comprising opioid-free monitored anesthesia care (MAC), a telehealth follow-up, and intraoperative waste reduction—or the control. The primary endpoint was postoperative pain at rest (PPR) and during movement (PPD) both at 24 h, measured with the Numeric Pain Rating Scale (NPRS). Secondary exploratory endpoints included SF-36, PSQ-18, TSQ test, LOS, and KgCO2 equivalent (KgCO2e) from surgical waste, patient transport, and complications. The interim analysis included patients completing a 30-day follow-up by 31 December 2024. Results: A total of 45 patients were enrolled (BuGS n = 18, control n = 27). While disproportionate, no significant differences were observed in PPR/PPD at 24 h (4.75 (3.725–5.875) vs. 4.5 (4.15–5.35); p = 0.626; 4 (3.10–4.75) vs. 4.6 (3.90–5.2); p = 0.130), confirmed using group ANOVA analysis (p = 0.515; p = 0.779, respectively). The BuGS group reported a reduced surgical room occupation (80.03 (64.84–101.87) vs. 133.23 (95.47–144.25) min; p = 0.002) and length of stay (0 (0–1) vs. 1 (1–2); p = 0.0001), without hospital unplanned admissions. Reduced KgCO2e emissions from waste disposal were reported, with no difference in SF-36, PSQ-18, and complication rates. Conclusions: If confirmed after complete accrual, BuGS could potentially promote a clinically equivalent, environmentally sustainable, and hospital efficient surgery without affecting the QoL of our patients. Further multicentric validation is warranted.Pubblicazioni consigliate
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