Evidence map›Paper›PMID 35769693›Full record

ArticleJournal of pain research2022

Sublingual Sufentanil versus Standard-of-Care (Patient-Controlled Analgesia with Epidural Ropivacaine/Sufentanil or Intravenous Morphine) for Postoperative Pain Following Pancreatoduodenectomy: A Randomized Trial.

Jesse Vincent Groen, S C Boon, M W Minderhoud, Bert A Bonsing, C H Martini, H Putter, A L Vahrmeijer, Monique van Velzen, J Vuijk, J S D Mieog and 1 more

Open access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 38% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
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

11 authors at 1 institution in 1 country.

Jesse Vincent GroenDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-2438-4665
S C BoonDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
M W MinderhoudDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
Bert A BonsingDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
C H MartiniDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
H PutterDepartment of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.
A L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Monique van VelzenDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-0289-6432
J VuijkDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
J S D Mieog *Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
A Dahan *Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0003-3161-3945
Leiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The optimal treatment strategy for postoperative pain following pancreatoduodenectomy remains unknown. The aim of this study was to investigate whether sublingual sufentanil tablet (SST) is a non-inferior analgesic compared to our standard-of-care (patient-controlled epidural analgesia [PCEA] or PCA morphine) in the treatment of pain following pancreatoduodenectomy. Methods: This was a pragmatic, strategy, open-label, non-inferiority, parallel group, randomized (1:1) trial. The primary outcome was an overall mean pain score (Numerical Rating Scale: 0-10) on postoperative days 1 to 3 combined. The non-inferiority margin was -1.5 since this difference was considered clinically relevant. Results: Between October 2018 and July 2021, 190 patients were assessed for eligibility and 36 patients were included in the final analysis: 17 patients were randomized to SST and 19 patients to standard-of-care. Early treatment failure in the SST group occurred in 2 patients (12%) due to inability to operate the SST system and in 2 patients (12%) due to severe nausea despite antiemetics. Early treatment failure in the standard-of-care group occurred in 2 patients (11%) due to preoperative PCEA placement failure and in 1 patient (5%) due to hemodynamic instability caused by PCEA. The mean difference in pain score on postoperative day 1 to 3 was -0.10 (95% CI -0.72-0.52), and therefore the non-inferiority of SST compared to standard-of-care was demonstrated. The mean pain score, number of patients reporting unacceptable pain (pain score >4), Overall Benefit of Analgesia Score, and patient satisfaction per postoperative day, perioperative hemodynamics and postoperative outcomes did not differ significantly between groups. Conclusion: This first randomized study investigating the use of SST in 36 patients following pancreatoduodenectomy showed that SST is non-inferior compared to our standard-of-care in the treatment of pain on postoperative days 1 to 3. Future research is needed to confirm that these findings are applicable to other settings.

Indexed as

epidural analgesiamorphinepancreatoduodenectomypostoperative painsufentanil

Identifiers

PMID35769693
PMCPMC9234185
OpenAlexW4283397588

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.