Preventing pAIn With NMDA Antagonists - Steroids in Thoracoscopic lObectomy Procedures (PAIN-STOP) Pilot Trial

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

The objective of the PAIN-STOP trial is to assess the feasibility of a larger randomized controlled trial (RCT) evaluating NMDA antagonists and IV steroids, as compared to placebo, in decreasing the chances of clinically significant persistent post-surgical pain (PPSP) after video assisted thoracoscopic surgeries (VATS). This is a multi-centre randomized, controlled clinical trial with a 2 x 2 factorial design. The pilot phase of the trial will recruit 48 patients and follow them for 3 months. Patients will be randomized to one of four groups: 1) NMDA active + Steroid placebo; 2) Steroid active + NMDA placebo; 3) NMDA active + Steroid active; 4) NMDA placebo + Steroid placebo.

Key facts

Study ID

NCT02950233

Run by

Population Health Research Institute

People needed

27

Starts

2017-05-04

Expected to finish

2019-03-31

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-75 years of age,
• Planned elective VATS pulmonary lobectomy,
• Provide written informed consent to participate.

You may not qualify if…

• Current pain on the same side of the chest of moderate to severe intensity (>3/10 in 0-10 numerical rating scale (NRS) - where 0=no pain, 10=maximum pain),
• Known intracranial mass or cerebral aneurysm or raised intraocular pressure,
• Severe renal impairment (creatinine clearance based GFR of <30ml/min),
• Allergies to one or more of the study medications,
• Steroid treatment > 10mg/day of Prednisolone or its equivalent for > 3 weeks within the last 3 months,
• History of schizophrenia or bipolar disorder,
• History of drug addiction (prescription or non-prescription drug addiction diagnosed by a physician, excluding alcohol),
• Current diagnosis of Cushing's syndrome,
• Pregnancy,
• Previous participation in the PAIN-STOP trial.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States
• St. Joseph's Healthcare — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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