Pain, Patient Satisfaction
Conditions
Keywords
patient-controlled sedation, totally implantable venous access devices, subcutaneous implanted venous port, local anesthesia, propofol, alfentanil, indwelling catheter
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.
Interventions
DRUGPropofol Alfentanil
Propofol and Alfentanil are self-administered by the participant.
Sponsors
Stefanie Seifert
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Procedural time consumption | after completion of procedure | From procedure start (local anesthesia injection) until end of procedure (last suture). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bradycardia | after completion of procedure | Defined as heart \< 40/minutes during the procedure |
| Hypoxia | after completion of procedure | Defined as Oxygen saturation \<90% or significant drop from baseline (\>5% SaO2 drop) during the procedure |
| Airway intervention (Chin lift) | after completion of procedure | Defined as intervention by staff with chin lift during the procedure |
| Respiratory rate | after completion of procedure | Defined as respiratory rate \<8/minute during the procedure |
| Sedation score at time points T1-T4 | during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal | Depth of sedation measured by Observer Assessment of Alertness/Sedation Scale OAAS |
| Pneumothorax | after completion of procedure | Physicians assessment after completion of procedure. |
| Arterial puncture | after completion of procedure | Physicians assessment after completion of procedure. |
Countries
Sweden
Outcome results
None listed