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

Completed

• Conditions: Pain; Patient Satisfaction

• Registration Number: NCT04631393
• Lead Sponsor: Stefanie Seifert

Brief 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).

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.

Study Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-17
• Study Start: 2021-04-14
• Status Verified: 2021-10
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants maximal pain level	10 minutes before discharge from recovery area	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.

Secondary Outcome Measures

Name	Time	Method
Procedural time consumption	after completion of procedure	From procedure start (local anesthesia injection) until end of procedure (last suture).
Delivered doses of propofol and alfentanil	after completion of procedure	The total dose of given sedation and analgesia.
Grading of implantation conditions by the implanting physician	after completion of procedure	The port-implanting physicians assessment of implantation conditions during the procedure on a numeric rating scale (0=worst possible, 10= best possible)
Participants overall satisfaction	10 minutes before discharge from recovery area	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
Participants satisfaction with staff	10 minutes before discharge from recovery area	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
Participants maximal pain from arm where infusion is	10 minutes before discharge from recovery area	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
Participants satisfaction with pain treatment during implantation	10 minutes before discharge from recovery area	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
Participants evaluation of the importance of receiving sedatives during the procedure	10 minutes before discharge from recovery area	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
Participants evaluation of the importance of being in control of sedation administration	10 minutes before discharge from recovery area	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

Trial Locations

Locations (1)

Länssjukhuset Ryhov; 🇸🇪 Jönköping, Sweden