Patient-Controlled Sedation in Port Implantation (PACSPI 2)-A Randomised Clinical Trial.

Optimising pain management during subcutaneous venous port (SVP) implantation is essential for patient-centred cancer care. However, evidence-based approaches to minimise intraoperative pain remain underexplored. This trial evaluated the clinical effectiveness and safety of the propofol-alfentanil patient-controlled sedation (PCS) technique as an adjunct to local anaesthesia (LA) for pain reduction during SVP implantation. Adult cancer patients at two Swedish anaesthesia departments received either LA + PCS or LA alone for SVP implantation. The primary outcome was the maximum intraoperative pain score on an 11-point numeric rating scale (NRS). Safety outcomes included respiratory, haemodynamic and insertion-related complications. Secondary outcomes assessed patient satisfaction and procedural measurements. A total of 340 patients (median age 70 [interquartile range, [IQR] 61-76], 51.8% male) were recruited between January 2023 and November 2024. Median intraoperative NRS pain scores were similar between groups (2 [0-3] vs. 2 [0-3], p = 0.292), with pain scores ≥ 4 reported in 22.9% (LA + PCS) and 22.2% (LA) (OR 0.96; 95% CI 0.57-1.60; p = 0.872). Hypoxia or obstructed airway occurred in 2/166 (1.2%) patients in the LA + PCS group and none in the LA group. Patient satisfaction was high in both groups (10 [10-10], p = 0.102). Optimal procedural conditions were reported more frequently with LA + PCS (96.4% vs. 82.0%; OR 5.84; 95% CI 2.36-14.44; p < 0.001), without affecting perioperative workflow. Propofol-alfentanil PCS does not significantly reduce intraoperative pain in patients during SVP implantation. Its routine use for pain reduction cannot be recommended. However, PCS may reasonably be offered to patients who prefer procedural sedation. EDITORIAL COMMENT: This randomised clinical trial found that adding patient-controlled sedation with propofol-alfentanil to standard local anaesthesia for subcutaneous venous port implantation does not have an impact on pain scores or patient satisfaction. Additional studies focusing on patients experiences and safety are recommended before implementing propofol-alfentanil patient-controlled sedation. Trial Registration: EudraCT number: 2021-003821-31; ClinicalTrials.gov identifier: NCT05688384.