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

• Status: Terminated
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Dexamethasone; Ketamine; Memantine; N-Methylaspartate; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• 18-75 years of age,

• Planned elective VATS pulmonary lobectomy,

• Provide written informed consent to participate.

Exclusion Criteria:

• 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.