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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: active motor cortex stimulation; Device: active prefrontal cortex stimulation; Device: tDCS sham motor cortex

• Registration Number: NCT03278184
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Study Start: 2017-10-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-11-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-11
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active motor cortex stimulation	active motor cortex stimulation	25 participants will have active stimulation targeting the left motor cortex for 20 minutes using transcranial direct current stimulation device.
active prefrontal cortex stimulation	active prefrontal cortex stimulation	25 participants will have active stimulation targeting the left dorsolateral prefrontal cortex for 20 minutes using transcranial direct current stimulation device.
tDCS sham motor cortex	tDCS sham motor cortex	25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.

Primary Outcome Measures

Name	Time	Method
the total consumption of morphine administered by patients during the first two days postoperative	48 hours postoperative	the investigator will calculate the amount of morphine used during the first two days postoperative.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Saeid Metwaly Elsawy; 🇪🇬 Assiut, Egypt

Saeid Elsawy; 🇬🇧 London, United Kingdom