drugset / Trial / NCT02950233

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

NCT02950233

Phase 3 Terminated 27 enrolled Population Health Research Institute
RandomizedFactorialQuadruple-blindTreatment

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.

Timeline

Start
2017-05-04
Primary completion
2018-12-31
Completion
2019-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 25 mg
Subject Ketamine Small molecule 0.1 mg/kg Intravenous
Subject Memantine Unknown 10 mg Oral

Indications