Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery

Study Overview
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Brief Summary
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The experience of pain derives from changes in brain excitability. Therefore, modulating the excitability of cortical areas involved in pain processing may become an attractive option in the context of multimodal analgesia during the postoperative period.

Detailed Description
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The combination of analgesic drugs acting on different mechanisms can potentiate the effects of analgesia. Moreover, the understanding of pain physiology at the molecular level supports the development of new specific drugs. Indeed, new neurophysiological models of pain processing by the brain are becoming exquisitely refined and are supported by electrophysiological and functional brain imaging studies. One of the interesting concepts that stemmed from these studies is the evidence that the experience of pain is reflected in the central nervous system by widespread activations and excitability changes within a network of interconnected cortical areas and subcortical structures. The network processing of noxious information and their limbic and emotional consequences has been termed the pain matrix. The continuous observation of the activity and excitability changes that parallel the pain experience led to the development of a new therapeutic approach: the use of central nervous system stimulation techniques.

Official Title
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The Role of Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery, Double Blinded Study

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: tDCS sham motor cortex
* Device: active prefrontal cortex stimulation
* Device: active motor cortex stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give informed consent to participate in the study. postoperative spine surgery patients(discectomy and/or laminectomy). American society of anesthesiology scores I to II patients. Exclusion Criteria: the participant who has any history of: an adverse reaction to brain stimulation. a seizure an unexplained loss of consciousness a stroke serious head injury surgery to their head any brain related, neurological illnesses any illness that may have caused brain injury frequent or severe headaches metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding any implanted medical devices such as cardiac pacemaker's or medical pumps taking any analgesic medications in the past 24 hours pregnancy anyone in your family has epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: tDCS sham motor cortex<br>25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device. | Device: tDCS sham motor cortex<br>* the intervention 25 participants will be subjected to spine surgery then participants will be subjected to sham stimulation targeting left motor cortex area using the transcranial direct current stimulation device for 30 seconds then stop for 20 minutes.<br>|
| Active Comparator: Active motor cortex stimulation<br>25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device. | Device: active motor cortex stimulation<br>* the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left motor cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min<br>|
| Active Comparator: active prefrontal cortex stimulation<br>25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device. | Device: active prefrontal cortex stimulation<br>* the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left dorsolateral prefrontal cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total consumption of morphine administered by patients during the first two days postoperative | the investigator will calculate the amount of morphine used during the first two days postoperative. | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity assessment using visual analogue scale (VAS score from 0-10) | the investigator will assess the pain at base line and at the end of sessions | 30 minutes after every sessions and at the third day | 
| HADS score | hospital anexiety and depression score | before surgery and at the third day |