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

• Status: Not yet recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Jönköping County
• Collaborator: Region Östergötland
• Treatments: Alfentanil; Propofol

Criteria

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