Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation

Pain, Postoperative Clinical Trial

— CMAPTPtDCS  

Official title:

Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005548
• Other study ID #: MF-VMA// 07.12.2015.
• Status: Completed
• Phase: Phase 2
• First received: December 24, 2016
• Last updated: March 27, 2018
• Start date: June 2016
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Military Medical Academy, Belgrade, Serbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• Transcranial direct current stimulation
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.

Drug:
• Morphine
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.

Locations

Country	Name	City	State
Serbia	Military Medical Academy, Department of Anesthesiology	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Military Medical Academy, Belgrade, Serbia

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

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 — View 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. — View 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Daily during five postoperative days	Five days
Secondary	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.	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 (?2-?5), and then every six hours (?6-?9) for five days.	Five days