Patient‐Controlled Sedation in Port Implantation ( PACSPI 2)—A Randomised Clinical Trial
Authors' conclusion
Propofol-alfentanil PCS does not significantly reduce intraoperative pain in patients during SVP implantation.
Study context
- Population
- Adult cancer patients undergoing subcutaneous venous port implantation at two Swedish anaesthesia departments
- Participants
- 340 patients
- Comparison
- Local anaesthesia (LA) + propofol-alfentanil patient-controlled sedation (PCS) vs LA alone for subcutaneous venous port (SVP) implantation
- LA + PCSn = 166
- Primary endpoint
- Maximum intraoperative pain score (11-point numeric rating scale (NRS))
Methodological detailsmulticentre, Recruited January 2023 to November 2024
- Multicentre
- Recruited January 2023 to November 2024
Primary result
As reported in the abstract
Maximum intraoperative NRS pain score
LA + PCS
2
median · IQR 0–3
LA
2
median · IQR 0–3
P = 0.292
Secondary outcomes
| Outcome | LA + PCS | LA | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Pain score ≥ 4 | 22.9% | 22.2% | 0.96 (0.57–1.60) | P = 0.872 | |
| Optimal procedural conditionsWithout affecting perioperative workflow | 96.4% | 82.0% | 5.84 (2.36–14.44) | P < 0.001 | |
| 0.050.21520Odds ratio (log scale) |
| Outcome | P value |
|---|---|
| Patient satisfaction | P = 0.102 |
Patient satisfaction
- High in both groups, median 10 [10-10]
Safety
| Outcome | LA + PCS | LA |
|---|---|---|
| Hypoxia or obstructed airway | 1.2% | 0 events |
Original publication
Patient‐Controlled Sedation in Port Implantation ( PACSPI 2)—A Randomised Clinical Trial. Acta Anaesthesiol Scand. Published 10 November 2025. doi:10.
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