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Table 1: Study summary including methods and outcomes.
Title
Project office
Objective
Eligibility criteria
Design and sample size
Study sites
Study groups
Interventions
Primary outcomes
Secondary outcomes
Tertiary outcomes
Follow-up
Preventing pAIn with Nmda antagonists-Steroids in T horacoscopic lObectomy P rocedures (PAINSTOP)
Population Health Research Institute, 237 Barton Street East, Hamilton, Ontario, Canada, L8L 2X2
Feasibility: To assess the feasibility of a larger RCT evaluating NMDA antagonists and IV steroids as
compared with placebo to decrease the chances of clinically significant PPSP after VATS lobectomies
Clinical: To determine the
* Effect of study interventions on the presence and intensity of PPSP at 3 months after surgery
* Rate of change in postoperative pain intensity measured over time
* Use of narcotic analgesic medication more than 4 weeks after surgery
* Presence of neuropathic pain
* Interference with the activities of daily living and thoracic surgery-specific activity limitations
* Change in global health status and quality of life
* Incidence of serious adverse effects
Inclusion: 18-75 years of age, undergoing elective VATS, and provided written, informed consent
Exclusion: Current pain on the same side of the chest of moderate to severe intensity, known
intracranial mass or cerebral aneurysm or raised intraocular pressure, severe renal impairment
(creatinine clearance-based glomerular filtration rate of less than 30 mL/min), allergy to one or
more of the study medications, history of schizophrenia or bipolar disease, history of drug addiction
(prescription or nonprescription drug addiction diagnosed by a physician, excluding alcohol), steroid
treatment with more than 10 mg/d of prednisolone or its equivalent for more than 3 weeks within the
past 3 months, current diagnosis of Cushing syndrome, pregnancy, or previous participation in the
PAIN-STOP trial
Multicenter RCT with two-by-two factorial design with 48 patients
St Joseph's Hospital at McMaster University in Hamilton, Canada, and Cleveland Clinic in Cleveland,
Ohio
(1) NMDA active + steroid placebo, (2) steroid active + NMDA placebo, (3) NMDA active + steroid
active, and (4) NMDA placebo + steroid placebo
NMDA treatment: Ketamine: 0.5 mg/kg IV bolus preincision and 0.1 mg/kg/hr infusion postoperatively
up to 24 hours; oral memantine: 5 mg BID (first week) and 10 mg BID (following 3 weeks)
Steroids: Two doses of dexamethasone 25 mg given prior to starting surgery and on the morning of
the second postoperative day
Proportion of (1) eligible patients recruited, (2) patients adhering to the study protocol, and (3)
patients completing the follow-up at 3 months
(1) Intensity of PPSP on a scale of 0-10 at 3 months postsurgery, (2) incidence of more than 3/10
PPSP with movement at 3 months, (3) the rate of change of postoperative pain intensity measured
over time (pain trajectory), (4) use for narcotic analgesic medication more than 3 d/wk beyond
4 weeks and up to 3 months, (5) presence of neuropathic pain, (6) interference with activities of
daily living based on the Brief Pain Inventory at 3 months, (7) thoracic surgery-specific activity
limitations assessed using a quantitative scale at 3 months, (8) change in health status using a global
impression of change scale at 3 months, and (9) quality of life (European Organization for Research
and Treatment of Cancer 30 scale) at 3 months
Incidence of (1) myocardial infarction and myocardial injury after noncardiac surgery; (2)
postoperative pneumonia; (3) surgical site infection; (4) need for new, positive-pressure ventilation;
and (5) prolonged air leak
In hospital, phone call at day 8 and month 2, and in-person follow-up visits at 1 month and 3 months
postrandomization; for patients who cannot attend in person, a telephone follow-up will be done
Abbreviations: BID, twice-a-day dose; IV, intravenous; NMDA, N-methyl-D-aspartate; PPSP, persistent postsurgical pain; RCT, randomized control trial;
VATS, video-assisted thoracoscopic surgeries.
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