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Recruiting NCT05688384

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

Conditions: Pain, Patient Satisfaction, Cancer, Venous Puncture

Sex: All
Ages: 18 Years – 110 Years
Phase: PHASE4
Enrollment: 340
Sponsor: Region Jönköping County

Location: Sweden

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.

Eligibility 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.PregnancyPrevious participation in study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05688384). StuddyBuddy aggregates publicly available trial information.