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

NCT03005548 | Completed Phase 2 DMC

• 1 other identifier: MF-VMA// 07.12.2015.
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Transcranial Direct Current Stimulation; Pain Postoperative; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  Five days

Study Arms (2)

Active tDCS

EXPERIMENTAL

Experimental: Transcranial direct current stimulation (tDCS). Patients assigned to the active treatment group (n=31) will receive IV morphine followed by IV morphine PCA (IV morphine bolus 1 mg, lockout time 10 mins.), preceded by tDCS (20 minutes of 2 milliamperes (mA) anodal tDCS over the ipsilateral cortex for 5days/week).

Device: Transcranial direct current stimulation; Drug: Morphine

Sham tDCS

SHAM COMPARATOR

Sham Control Group: Patients assigned to the control group (n=31) will receive IV morphine followed by IV morphine PCA (IV morphine bolus 1 mg, lockout time 10 mins.), preceded by sham tDCS stimulation (30 sec over the ipsilateral cortex, 5 days/week).

Drug: Morphine

Interventions

Transcranial direct current stimulation DEVICE

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.

Also known as: tDCS

Active tDCS

Morphine DRUG

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.

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Military Medical Academy, Belgrade, Serbia: lead

Study Sites (1)

Military Medical Academy, Department of Anesthesiology

Belgrade, Serbia

Location

Related Publications (4)

• 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.

  PMID: 23719070 RESULT

• 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.

  PMID: 23370085 RESULT

• 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.

  PMID: 21470608 RESULT

• 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.

  PMID: 32161547 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Transcranial Direct Current Stimulation; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Tihomir V Ilic, MD, PhD

  Military Medical Academy, Bulgaria

  STUDY CHAIR

• Dusica M Stamenkovic, MD, PhD

  Military Medical Academy, Bulgaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD, Anesthesiologist

Study Record Dates

• First Submitted: December 24, 2016
• First Posted: December 29, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

SE (1)