Clinical trial NCT03005548: Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation
Official title: Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: Transcranial Direct Current Stimulation
Pain Postoperative
Thoracotomy
Lead sponsor: Military Medical Academy, Belgrade, Serbia
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subject is willing and able to provide written informed consent,
* Subject is 18-80 years old,
* Subject needs thoracotomy for confirmed malignant lung disease,
* Subject is extubated in the operating room

Exclusion Criteria:

* Subject is pregnant
* Subject is in treatment for psychiatric disease
* Subject is in treatment for neurological disease
* Subject is in treatment for chronic pain
* Subject has history of current or past alcohol or Street Drug abuse
* Subject has received chemotherapy
* Subject has history of previous thoracic or cardiac surgery
* Subject is allergic to medications that will be used in the study
* Subject has pacemaker or automatic implantable cardioverter/defibrillator
* Subject has implants or any other devices in the head, the spinal cord or peripheral nerves
* Subject has confirmed brain lesion, including tumor or metastasis

Primary outcomes:
measure: Amount of morphine used for treatment of pain after thoracotomy in a group of patients receiving tDCS combined with intravenous morphine PCA compared with a group of patients receiving sham stimulation combined with intravenous morphine PCA.
timeFrame: Five days
Secondary outcomes:
measure: Pain scores measured using visual analogue scale (VAS) at rest, during movement and during cough in patients receiving tDCS combined and IV morphine PCA compared with patients receiving sham stimulation and IV morphine PCA.
timeFrame: Five days
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Military Medical Academy, Department of Anesthesiology
Study officials:
affiliation: Military Medical Academy, Bulgaria
name: Tihomir V Ilic, MD, PhD
role: STUDY_CHAIR
affiliation: Military Medical Academy, Bulgaria
name: Dusica M Stamenkovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dubois PE, Ossemann M, de Fays K, De Bue P, Gourdin M, Jamart J, Vandermeeren Y. Postoperative analgesic effect of transcranial direct current stimulation in lumbar spine surgery: a randomized control trial. Clin J Pain. 2013 Aug;29(8):696-701. doi: 10.1097/AJP.0b013e31826fb302.
citation: Borckardt JJ, Reeves ST, Robinson SM, May JT, Epperson TI, Gunselman RJ, Schutte HD, Demos HA, Madan A, Fredrich S, George MS. Transcranial direct current stimulation (tDCS) reduces postsurgical opioid consumption in total knee arthroplasty (TKA). Clin J Pain. 2013 Nov;29(11):925-8. doi: 10.1097/AJP.0b013e31827e32be.
citation: Borckardt JJ, Romagnuolo J, Reeves ST, Madan A, Frohman H, Beam W, George MS. Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study. Gastrointest Endosc. 2011 Jun;73(6):1158-64. doi: 10.1016/j.gie.2011.01.050. Epub 2011 Apr 5.
citation: Stamenkovic DM, Mladenovic K, Rancic N, Cvijanovic V, Maric N, Neskovic V, Zeba S, Karanikolas M, Ilic TV. Effect of Transcranial Direct Current Stimulation Combined With Patient-Controlled Intravenous Morphine Analgesia on Analgesic Use and Post-Thoracotomy Pain. A Prospective, Randomized, Double-Blind, Sham-Controlled, Proof-of-Concept Clinical Trial. Front Pharmacol. 2020 Feb 25;11:125. doi: 10.3389/fphar.2020.00125. eCollection 2020.