Evidence map›Paper›PMID 32104059›Full record

ArticleJournal of pain research2020

N-Methyl-D-Aspartate Antagonists and Steroids for the Prevention of Persisting Post-Surgical Pain After Thoracoscopic Surgeries: A Randomized Controlled, Factorial Design, International, Multicenter Pilot Trial.

Harsha Shanthanna, Alparslan Turan, Jessica Vincent, Remie Saab, Yaron Shargall, Turlough O'Hare, Kimberly Davis, Sylvanus Fonguh, Kumar Balasubramaniam, James Paul and 6 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of pain research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02950233 (NMDA Antagonists and Steroids for the Prevention of Persisting Post-Surgical Pain After Thoracoscopic Surgeries), 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
0.8field-weighted citation impact, top 28% 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.

NCT02950233 phase3terminatednot on this map

NMDA Antagonists and Steroids for the Prevention of Persisting Post-Surgical Pain After Thoracoscopic Surgeries: A Randomized Controlled, Factorial Design, International, Multicentre Pilot Study

TypeinterventionalSponsorPopulation Health Research InstituteRan2017 to 2019Enrolled27ConditionsPain, PostoperativeArmsNMDA active, Steroid active, NMDA placebo, Steroid placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 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

16 authors at 7 institutions in 3 countries.

Harsha ShanthannaDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada.ORCID 0000-0002-4105-4465
Alparslan TuranDepartment of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA.
Jessica VincentPopulation Health Research Institute, Hamilton, ON, Canada.
Remie SaabDepartment of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-6968-7988
Yaron ShargallDepartment of Surgery, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
Turlough O'HareDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada.
Kimberly DavisAcute Pain Service, St. Joseph Healthcare Hamilton, Hamilton, ON, Canada.ORCID 0000-0001-5872-9038
Sylvanus FonguhPopulation Health Research Institute, Hamilton, ON, Canada.
Kumar BalasubramaniamPopulation Health Research Institute, Hamilton, ON, Canada.
James PaulDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada.
Ian GilronDepartments of Anesthesiology and Perioperative Medicine, Biomedical and Molecular Sciences, Centre for Neuroscience Studies and School of Policy Studies, Queen's University, Kingston, ON, Canada.ORCID 0000-0002-5293-8792
Henrik KehletSection of Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-2209-1711
Daniel I SesslerDepartment of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9932-3077
Mohit BhandariDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
P J DevereauxDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.ORCID 0000-0003-2935-637X
McMaster University · CACleveland Clinic · USPopulation Health Research Institute · CAImpact · CASt. Joseph’s Healthcare Hamilton · CAQueen's University · CARigshospitalet · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe conducted a feasibility 2×2 factorial trial comparing N-methyl-D-aspartate (NMDA) antagonists (intravenous ketamine and oral memantine) versus placebo and intravenous steroids versus placebo, in patients having elective video-assisted thoracic surgery lobectomies, at St. Joseph's Hamilton, Canada, and Cleveland Clinic, Cleveland, USA. Our feasibility objectives were: 1) recruitment rate/week; 2) recruitment of ≥90% of eligible patients; and 3) >90% follow-up. Secondary objectives were incidence and intensity of persistent post-surgical pain (PPSP) and other clinical and safety outcomes.

methodsUsing computerized randomization, patients were allocated to one of four groups: NMDA active with steroid placebo; NMDA placebo with steroid active; both NMDA and steroid active; both NMDA and steroid placebo. Patients, health providers, and data analysts were blinded to allocation. Patients were followed for 3 months after randomization.

resultsThe trial was initiated in May 2017 at Hamilton and, after subsequent regulatory and ethics approval, in April 2018 at Cleveland. The trial had to be stopped after only 1 month of recruitment in Cleveland because the packaged study medications (memantine) expired and we were unable to procure the dosage required. Among 41 eligible patients, 27 (66%) were randomized. The recruitment rate/week was 0.63, 95% confidence interval (CI): 0.47-0.79 in Hamilton; and 1, 95% CI: 0.83-1.17 in Cleveland. Follow-up was complete for all 24 patients (100%) in Hamilton, and 3 of 4 patients in Cleveland. In total, only 4 patients (15%), and 2 patients (7%) had persistent pain at rest and with movement, respectively. There were no significant differences between groups for other outcomes.

conclusionThe trial had to be stopped prematurely due to non-availability of study medications. Trial feasibility objectives of recruiting 90% of eligible patients and recruiting at least one patient/week per site were not met. Consideration for protocol changes will be necessary for the full trial.

trial registrationNCT02950233.

Indexed as

chronic painketamineNMDA antagonistspersisting painpreventionsteroids

Identifiers

PMID32104059
PMCPMC7024793
OpenAlexW3006418348

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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 OpenQuestion graph.