Trial reportPloS one2026
Quality of recovery (QoR-15) after patient-controlled sedation during venous port implantation: A prespecified substudy of the PACSPI-2 randomised clinical trial.
Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05688384 (Patient-Controlled Sedation in Port Implantation), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Patient-Controlled Sedation in Port Implantation (PACSPI-2) -a Randomized Controlled Trial
Who cites it
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPostoperative 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.
objectiveTo 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
settingPrespecified substudy of a randomised, open-label clinical trial conducted at two Swedish anaesthesia departments. PATIENTS: Three hundred thirty-four adult patients with cancer.
interventionsLocal anaesthesia (LA) alone or LA combined with propofol-alfentanil PCS during SVP implantation.
main outcome measuresPrimary outcome was difference of postoperative total QoR-15 scores between groups. The primary endpoint of the parent PACSPI-2 trial was maximal intraprocedural pain.
resultsThere 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.
conclusionsEarly 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 registrationEuropean Union Clinical Trials Registry: EudraCT: 2021-003821-31, ClinicalTrials.gov: NCT05688384.
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