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. TRIAL REGISTRATION: European Union Clinical Trials Registry: EudraCT: 2021-003821-31, ClinicalTrials.gov: NCT05688384.