Patient-Controlled Sedation in Port Implantation (PACSPI-2)

Summary

The goal of the study is to determine if patient-controlled sedation (PCS) with propofol and alfentanil reduces patient-reported pain perception during implantation of subcutaneous venous port (SVP). The main question it aims to answer: How much pain did you (patient) experience during SVP-implantation Several other questions will be answered regarding: patient´s perception of the procedure, complication rate, procedure data. The study contains two groups which will be compared. Control group: will do SVP implantation under local anaesthesia Study group: will do SVP implantation under local anaesthesia and patient-controlled sedation. The patients are asked to complete a questionnaire postoperatively which contains questions on pain perception and satisfaction.

Timeline

Start

2023-01-19

Primary completion

2024-11-08

Completion

2024-11-08

Publications

• Background Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.
• Background Grossmann B, Nilsson A, Sjoberg F, Bernfort L, Nilsson L. Patient-controlled sedation with propofol for endoscopic procedures-A cost analysis. Acta Anaesthesiol Scand. 2020 Jan;64(1):53-62. doi: 10.1111/aas.13463. Epub 2019 Oct 10.
• Background Kreienbuhl L, Elia N, Pfeil-Beun E, Walder B, Tramer MR. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses. Anesth Analg. 2018 Oct;127(4):873-880. doi: 10.1213/ANE.0000000000003361.
• Background Clements W, Sneddon D, Kavnoudias H, Joseph T, Goh GS, Koukounaras J, Snow T. Randomized and controlled study comparing patient controlled and radiologist controlled intra-procedural conscious sedation, using midazolam and fentanyl, for patients undergoing insertion of a central venous line. J Med Imaging Radiat Oncol. 2018 Dec;62(6):781-788. doi: 10.1111/1754-9485.12817. Epub 2018 Oct 8.
• Background Burlacu CL, McKeating K, McShane AJ. Remifentanil for the insertion and removal of long-term central venous access during monitored anesthesia care. J Clin Anesth. 2011 Jun;23(4):286-91. doi: 10.1016/j.jclinane.2010.12.007.
• Seifert S, Taxbro K, Nilsson A, Azman J, Chew MS, Hammarskjold F. Patient-Controlled Sedation in Port Implantation (PACSPI 2)-A Randomised Clinical Trial. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70148. doi: 10.1111/aas.70148.

Drugs

Indications