Evidence map›Paper›PMID 41214479›Full record

Trial reportActa anaesthesiologica Scandinavica2026

Patient-Controlled Sedation in Port Implantation (PACSPI 2)-A Randomised Clinical Trial.

Stefanie Seifert, Knut Taxbro, Andreas Nilsson, Josip Azman, Michelle S Chew, Fredrik Hammarskjöld

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Acta anaesthesiologica Scandinavica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05688384 (Patient-Controlled Sedation in Port Implantation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05688384 phase4completednot on this map

Patient-Controlled Sedation in Port Implantation (PACSPI-2) -a Randomized Controlled Trial

TypeinterventionalSponsorRegion Jönköping CountyRan2023 to 2024Enrolled340ConditionsPain, Patient Satisfaction, Cancer, Venous PunctureArmsPropofol + Alfentanil
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Stefanie SeifertDepartment of Anaesthesia and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden.ORCID 0000-0001-5986-4004
Knut TaxbroDepartment of Anaesthesia and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden.
Andreas NilssonDepartment of Anaesthesia and Intensive Care, Linköping University Hospital, Linköping, Sweden.ORCID 0000-0002-1217-2163
Josip AzmanDepartment of Anaesthesia and Intensive Care, Linköping University Hospital, Linköping, Sweden.
Michelle S ChewDepartment of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Fredrik HammarskjöldDepartment of Anaesthesia and Intensive Care Medicine, Ryhov County Hospital, Jönköping, Sweden.

Funding

Futurum - Akademin för Hälsa och Vård, Region Jönköpings läns Futurum-963747
6 · The paper itself

Abstract

Optimising pain management during subcutaneous venous port (SVP) implantation is essential for patient-centred cancer care. However, evidence-based approaches to minimise intraoperative pain remain underexplored. This trial evaluated the clinical effectiveness and safety of the propofol-alfentanil patient-controlled sedation (PCS) technique as an adjunct to local anaesthesia (LA) for pain reduction during SVP implantation. Adult cancer patients at two Swedish anaesthesia departments received either LA + PCS or LA alone for SVP implantation. The primary outcome was the maximum intraoperative pain score on an 11-point numeric rating scale (NRS). Safety outcomes included respiratory, haemodynamic and insertion-related complications. Secondary outcomes assessed patient satisfaction and procedural measurements. A total of 340 patients (median age 70 [interquartile range, [IQR] 61-76], 51.8% male) were recruited between January 2023 and November 2024. Median intraoperative NRS pain scores were similar between groups (2 [0-3] vs. 2 [0-3], p = 0.292), with pain scores ≥ 4 reported in 22.9% (LA + PCS) and 22.2% (LA) (OR 0.96; 95% CI 0.57-1.60; p = 0.872). Hypoxia or obstructed airway occurred in 2/166 (1.2%) patients in the LA + PCS group and none in the LA group. Patient satisfaction was high in both groups (10 [10-10], p = 0.102). Optimal procedural conditions were reported more frequently with LA + PCS (96.4% vs. 82.0%; OR 5.84; 95% CI 2.36-14.44; p < 0.001), without affecting perioperative workflow. Propofol-alfentanil PCS does not significantly reduce intraoperative pain in patients during SVP implantation. Its routine use for pain reduction cannot be recommended. However, PCS may reasonably be offered to patients who prefer procedural sedation. EDITORIAL COMMENT: This randomised clinical trial found that adding patient-controlled sedation with propofol-alfentanil to standard local anaesthesia for subcutaneous venous port implantation does not have an impact on pain scores or patient satisfaction. Additional studies focusing on patients experiences and safety are recommended before implementing propofol-alfentanil patient-controlled sedation. Trial Registration: EudraCT number: 2021-003821-31; ClinicalTrials.gov identifier: NCT05688384.

Indexed as

Analgesia, Patient-ControlledVascular Access DevicesAgedAlfentanilAnesthesia, LocalFemaleHumansMaleMiddle AgedPain ManagementPain MeasurementPatient SatisfactionProcedural SedationPropofolAlfentanilPropofolanalgosedationcentral venous catheter insertionpain scorepatient‐controlled sedationPCSsubcutaneous venous port implantationTIVAD

Identifiers

PMID41214479
PMCPMC12602766

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.