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PainPACSPI-1NCT04631393

Patient-controlled Sedation in Port Implantation (PACSPI-1)

An observational study of Pain and Patient Satisfaction, run by Stefanie Seifert at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP). Read more about this study

Who is it for?
Ages 18 to 105 years
Conditions the study is for
Pain, Patient Satisfaction
What is being tested?
Propofol Alfentanil
How many people
40 participants
Where
1 siteSweden
Study dates
14 Apr 2021to 15 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients ≥18 years scheduled for SVP implantation at Ryhov County Hospital.

Who may be able to join

  • Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital.

Who cannot join

  • Inability to operate the PCS apparatus,
  • Inability to communicate in Scandinavian languages.
  • Patients who require general anaesthesia or patients eligible for local anaesthesia only (i.e. severe sleep apnea).
  • Propofol or alfentanil allergy.
  • Intake of food (or clear fluids) within six (or two) hours prior to the procedure.
  • Failure to achieve peripheral vascular access.
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Länssjukhuset Ryhov

    Jönköping, 55185

Other trials in Sweden

About this study

Official title: Patient-controlled Sedation in Port Implantation (PACSPI-1)-a Feasibility Trial

The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).

Read the detailed description

The main objective of this trial is to study the feasibility of (PCS) with propofol and alfentanil during SVP implantation.

Participants included in the study are able to administer a combination of propofol and alfentanil using a patient-controlled sedation pump. This allows the patient to self-control their sedation/analgesia during SVP implantation. The pump enables the patient via a hand-held button to trigger the release of a single bolus. A bolus of 0.5ml programmed into the pump contains a combination of 4.5mg propofol and 25µg alfentanil and is administered under a 7 second period resulting in a maximal amount of 8 bolus doses per minute.

Each SVP implantation procedure is separated into four time points at which sedation scores are recorded. Patients are monitored by anaesthesia staff and SVP implantation is performed by an anaesthesiologist according to hospital protocol.

Participants are asked to fill in a written questionnaire to indicate pain score and satisfaction with the procedure when ready for discharge.

Adverse events, time consumption and operators satisfaction with implantation conditions are recorded periprocedural.

The result of this trial will provide guidance for a larger randomized trial (PACSPI-2) comparing several clinically relevant aspects of the use of PCS and local anesthesia (LA) versus LA alone during SVP implantation.

Being tested
Propofol Alfentanil
Keywords
patient-controlled sedation, totally implantable venous access devices, subcutaneous implanted venous port, local anesthesia, propofol, alfentanil, indwelling catheter
Medical subject headings
Pain, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Propofol AlfentanilDrug

    Also called Propofol/Alfentanil self-administration

    Propofol and Alfentanil are self-administered by the participant.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants maximal pain level

    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.

    Measured: 10 minutes before discharge from recovery area

Secondary outcomes (9)

  1. Procedural time consumption

    From procedure start (local anesthesia injection) until end of procedure (last suture).

    Measured: after completion of procedure

  2. Delivered doses of propofol and alfentanil

    The total dose of given sedation and analgesia.

    Measured: after completion of procedure

  3. Grading of implantation conditions by the implanting physician

    The port-implanting physicians assessment of implantation conditions during the procedure on a numeric rating scale (0=worst possible, 10= best possible)

    Measured: after completion of procedure

  4. Participants overall satisfaction

    Participants assessment of overall satisfaction experienced during the procedure using a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire

    Measured: 10 minutes before discharge from recovery area

  5. Participants satisfaction with staff

    Participants assessment of satisfaction with the staff using a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire

    Measured: 10 minutes before discharge from recovery area

  6. Participants maximal pain from arm where infusion is

    Participants assessment of pain from arm with the infusion using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire

    Measured: 10 minutes before discharge from recovery area

  7. Participants satisfaction with pain treatment during implantation

    Participants assessment of satisfaction with pain treatment on a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire

    Measured: 10 minutes before discharge from recovery area

  8. Participants evaluation of the importance of receiving sedatives during the procedure

    Participants assessment of the importance of receiving sedatives on a numeric rating scale from 0-10 (0=not important, 10=very important) on patient questionnaire

    Measured: 10 minutes before discharge from recovery area

  9. Participants evaluation of the importance of being in control of sedation administration

    Participants assessment of the importance of being in control of sedation administration on a numeric rating scale from 0-10 (0=not important, 10=very important) on patient questionnaire

    Measured: 10 minutes before discharge from recovery area

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start14 Apr 2021
  3. Primary completion15 Oct 2021
  4. Study completion15 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04631393
Sponsor's protocol ID
EPM 2020-02642
Acronym
PACSPI-1
Status last verified
Oct 2021
First submitted
10 Nov 2020
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication will be available for sharing on request.

Publications

  • 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.

    PubMed 31005243

  • 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.

    PubMed 30295410

  • 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.

    PubMed 29750696

  • Grossmann B, Nilsson A, Sjoberg F, Nilsson L. Patient-controlled Sedation During Flexible Bronchoscopy: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2020 Apr;27(2):77-85. doi: 10.1097/LBR.0000000000000610.

    PubMed 31478938

  • Taxbro K, Berg S, Hammarskjold F, Hanberger H, Malmvall BE. A prospective observational study on 249 subcutaneous central vein access ports in a Swedish county hospital. Acta Oncol. 2013 Jun;52(5):893-901. doi: 10.3109/0284186X.2013.770601. Epub 2013 Feb 22.

    PubMed 23432403

  • Seifert S, Taxbro K, Hammarskjold F. Patient-Controlled Sedation in Port Implantation (PACSPI 1) - A feasibility trial. BJA Open. 2022 Jul 31;3:100026. doi: 10.1016/j.bjao.2022.100026. eCollection 2022 Sep.

    PubMed 37588584

Questions about this trial

What is this clinical trial studying?

An observational study of Pain and Patient Satisfaction, run by Stefanie Seifert at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants maximal pain level (time frame: 10 minutes before discharge from recovery area). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631393, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.

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