Clinical trial · Interventional
Patient-Controlled Sedation in Port Implantation (PACSPI-2)
Patient-Controlled Sedation in Port Implantation (PACSPI-2) -a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
| Patient Satisfaction | — | UNRESOLVED | — |
| Venous Puncture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Propofol + Alfentanil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control arm (LA)
- description
- Patients in this arm will undergo SVP insertion in local anesthesia (LA)
- type
- ACTIVE_COMPARATOR
- label
- Study arm (LA+PCS)
- description
- Patients in this arm will undergo SVP insertion in local anesthesia and PCS (LA+PCS)
- interventionNames
- Drug: Propofol + Alfentanil
Primary outcomes (1)
- measure
- Maximal intraprocedural pain level on numeric rating scale
- timeFrame
- after completion of procedure 10 minutes before discharge
- description
- NRS Participants assessment of maximal pain level experienced during the procedure using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥18 years with cancer in need of SVP. Exclusion Criteria: * Inability to operate the PCS apparatus. * Inability to communicate in Scandinavian languages. * Patients who require general anaesthesia or patients eligible for LA only on anesthesiologist´s assessment (i.e. severe sleep apnea). * Propofol or alfentanil allergy. * Non-fasting according to guidelines of the Swedish Society for Anaesthesia and Intensive Care (SFAI). * Failure to achieve peripheral vascular access. * Pregnancy * Previous participation in study
References
Publications (6)
- BACKGROUNDTaxbro 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. PMID 31005243
- BACKGROUNDGrossmann 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. PMID 31436310
- BACKGROUNDKreienbuhl 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. PMID 29750696
- BACKGROUNDClements 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. PMID 30295410
- BACKGROUNDBurlacu 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. PMID 21663812
- DERIVEDSeifert 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. PMID 41214479