Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this single center, prospective, randomized, double blind clinical
      trial is to evaluate the effectiveness of anodal transcranial direct current stimulation
      (tDCS) combined with patient controlled analgesia (PCA) morphine, on intravenous morphine use
      for postoperative analgesia after thoracotomy. The intervention group will receive treatment
      with anodal tDCS, whereas the control group will receive sham stimulation.
    

Detailed description: 
      tDCS has been used for treatment of chronic pain states, but experience with the use of tDCS
      for treatment of acute postoperative pain is limited. tDCS has been used for postoperative
      analgesia after lumbar spine surgery, total knee arthroplasty and for post-procedural pain
      after endoscopic retrograde cholangiopancreatography.

      This study investigates the effects of tDCS vs. sham stimulation combined with IV morphine
      PCA on postoperative morphine consumption for analgesia after thoracotomy for lung cancer.

      Patients with malignant lung disease requiring thoracotomy will be randomly assigned to
      active stimulation or sham stimulation in a double-blind, sham-controlled, parallel design
      clinical trial. Each group will receive IV morphine PCA and tDCS vs. IV morphine PCA and sham
      stimulation daily, starting with arrival in the post-anesthesia care unit on the day of
      surgery and continuing for the first four postoperative days. Anodal tDCS with direct current
      at intensity 2 mA will be delivered for 20 minutes on five consecutive days, whereas sham
      stimulation will last for 30 seconds.

      Morphine consumption, the number of analgesia demands, and pain intensity at rest, during
      movement and with cough will be recorded at predetermined time intervals as follows: After
      surgery, when VAS pain score at rest falls below 30 mm, tDCS will be applied. VAS pain will
      be measured immediately before the intervention (T0) and immediately after the intervention
      (T1), and then regularly every one hour for the four hours (Т2-Т5), and then every six hours
      (Т6-Т9) for five days.
    

Intervention name(s): Transcranial direct current stimulation; Morphine
Intervention type(s): Device; Drug
Intervention description(s): Transcranial direct current stimulation. All eligible patients will be treated with patient-controlled IV morphine analgesia by PCA (PCA pump (CADD-Legacy PCA Pump, Deltec, Inc.) IV morphine bolus 1 mg, lockout time 10 mins.).
Device: wireless tDCS (StarStim, NeuroElectrics) non-invasive brain stimulation with a pair of electrodes with saline-soaked pads for delivery of direct current at intensity 2 mA for 20 mins.; In Sham comparator group All eligible patients will be treated with patient-controlled IV morphine analgesia (PCA) (PCA pump (CADD-Legacy PCA Pump (Deltec, Inc.) morphine IV bolus 1 mg, lockout time 10 mins).
Device: wireless tDCS (StarStim, NeuroElectrics) non-invasive brain stimulation with a pair of electrodes with saline-soaked pads for delivery of direct current at intensity 2 mA for 30s at the beginning.
Other intervention name(s): tDCS
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation; Pain Postoperative; Thoracotomy