N-methyl-D-aspartate antagonists and steroids for the prevention of persisting postsurgical pain after thoracoscopic surgeries: A randomized controlled, factorial design, international, multicenter pilot trial
Journal of Pain Research Feb 20, 2020
Shanthanna H, Turan A, Vincent J, et al. - Researchers conducted feasibility 2× 2 factorial trial including patients having elective video-assisted thoracic surgery lobectomies, at St. Joseph’s Hamilton, Canada, and Cleveland Clinic, Cleveland, USA in order to compare N-methyl-D-aspartate (NMDA) antagonists (intravenous ketamine and oral memantine) vs placebo and intravenous steroids vs placebo. For feasibility, they determined: 1) recruitment rate/week; 2) recruitment of ≥ 90% of eligible patients; and 3) > 90% follow-up. Incidence and intensity of persistent postsurgical pain (PPSP) and other clinical and safety outcomes were assessed as secondary objectives. Allocation of patients to one of the following four groups was done using computerized randomization: NMDA active with steroid placebo; NMDA placebo with steroid active; both NMDA and steroid active; both NMDA and steroid placebo. Initiation of the trial was done in May 2017 at Hamilton and, in April 2018 at Cleveland. The premature stoppage of the trial was done due to the non-availability of study medications. Among 41 eligible patients, 27 (66%) were randomized. All 24 patients (100%) in Hamilton and 3 of 4 patients in Cleveland had complete follow-up. Persistent pain at rest and with movement was reported in only 4 patients (15%), and 2 patients (7%), respectively. The groups did not show significant differences in other outcomes. They did not meet the trial feasibility objectives of recruiting 90% of eligible patients and recruiting at least one patient/week per site.
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