TerminatedPhase 3Other

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

NCT ID

NCT02950233

Target Enrollment

27 participants

Start Date

2017-05-04

Est. Completion

2019-03-31

About This Study

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.

Conditions Studied

Pain, Postoperative

Interventions

•NMDA active
•Steroid active
•NMDA placebo
•Steroid placebo

Eligibility

Age:18 Years - 75 Years

Healthy Volunteers:No

View full eligibility 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.

Study Locations (2)

Cleveland Clinic

Cleveland, Ohio, United States

St. Joseph's Healthcare