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

NCT05688384 | Completed Phase 4 DMC

• 1 other identifier: EUDRACT: 2021-003821-31
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Patient Satisfaction; Cancer; Venous Puncture

Keywords

patient-controlled sedation; totally implantable venous access device; subcutaneous implanted venous port; local anesthesia; propofol; alfentanil; indwelling catheter

Outcome Measures

Primary Outcomes (1)

• Maximal intraprocedural pain level on numeric rating scale

  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.

  after completion of procedure 10 minutes before discharge

Secondary Outcomes (15)

• Participants overall satisfaction, Participants satisfaction with staff

  after completion of procedure 10 minutes before discharge

• Number of participants with arterial puncture, pneumothorax, bradycardia, hypoxia, airway intervention, bradypnea

  during the procedure

• Sedation score on Observers Assessment of Alertness/Sedation scale (OAA/S)

  during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal

• type of catheter

  during the procedure

• amount and type of local anaesthesia

  during the procedure

Study Arms (2)

Control arm (LA)

NO INTERVENTION

Patients in this arm will undergo SVP insertion in local anesthesia (LA)

Study arm (LA+PCS)

ACTIVE COMPARATOR

Patients in this arm will undergo SVP insertion in local anesthesia and PCS (LA+PCS)

Drug: Propofol + Alfentanil

Interventions

Propofol + Alfentanil DRUG

In addition to LA, patients in the study group are able to self-administer a combination of propofol and alfentanil using a patient-controlled sedation pump. The pump enables the patient via a hand-held button to trigger the release of a single bolus of 0.5ml containing 4.5mg propofol and 25µg alfentanil under an 10second period. This results in a maximal possible amount of 6 bolus doses per minute.

Study arm (LA+PCS)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years with cancer in need of SVP.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Jönköping County: lead
• Region Östergötland: collaborator

Study Sites (1)

Länssjukhuset Ryhov

Jönköping, 555185, Sweden

Location

Related Publications (6)

• 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.

  PMID: 31005243 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.

  PMID: 31436310 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.

  PMID: 29750696 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.

  PMID: 30295410 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.

  PMID: 21663812 BACKGROUND

• 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.

  PMID: 41214479 DERIVED

MeSH Terms

Conditions

Pain; Patient Satisfaction; Neoplasms

Interventions

Propofol; Alfentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stefanie Seifert

  Region Jönköping

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 18, 2023
• Study Start: January 19, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The supporting information will be available from november 2022.
• Access Criteria: Requests for sharing IPD that underlie results in a publication can be made to the principal investigator. The supporting information will be available on researchgate.com.

Locations

SE (1)