Quality of recovery (QoR-15) after patient-controlled sedation during venous port implantation: A prespecified substudy of the PACSPI-2 randomised clinical trial

Background: Postoperative recovery after subcutaneous venous port implantation is generally considered uncomplicated; however, patient-reported recovery outcomes in patients with cancer remain poorly characterized. The impact of patient-controlled sedation (PCS) on postoperative recovery has not been established. Objective: To assess early postoperative recovery using the Quality of Recovery-15 (QoR-15) questionnaire in a prespecified substudy of the PACSPI-2 randomised clinical trial and to compare recovery between patients receiving local anaesthesia alone and those receiving local anaesthesia combined with patient-controlled sedation. Design and setting: Prespecified substudy of a randomised, open-label clinical trial conducted at two Swedish anaesthesia departments. Patients: Three hundred thirty-four adult patients with cancer. Interventions: Local anaesthesia (LA) alone or LA combined with propofol-alfentanil PCS during SVP implantation. Main outcome measures: Primary outcome was difference of postoperative total QoR-15 scores between groups. The primary endpoint of the parent PACSPI-2 trial was maximal intraprocedural pain. Results: There was no overall difference in total postoperative QoR-15 scores between the treatment groups (P = 0.61). Total QoR-15 scores changed significantly over time (P < 0.001) in both groups. By postoperative day 1 (POD 1), mean QoR-15 scores had increased from baseline in both groups (mean difference 2.9 and 3.1, respectively; P = 0.02 for both), although these changes were below the published minimal clinically important difference (MCID) of 6. Before discharge, the LA + PCS group showed its largest within-group improvement in QoR-15 (mean difference 5.6, P < 0.001), primarily driven by the “Emotional state” and “Psychological support” dimensions, however no significant between group differences were observed. Median pain scores on POD 1 were 3 (IQR 2–5) in both groups, with NRS ≥ 4 reported by 49% in the LA and 48% in the LA + PCS group. Conclusions: Early postoperative recovery after subcutaneous venous port implantation was generally good and did not differ between the LA and LA + PCS group. A transient within-group improvement in emotional and psychological recovery domains was observed before discharge in the LA + PCS group. Pain on POD 1 remained common in both groups. These findings were based on secondary analyses and should therefore be considered exploratory. © 2026, Seifert et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. http://creativecommons.org/licenses/by/4.0/