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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: tDCS sham motor cortex; Device: active motor cortex stimulation; Device: active prefrontal cortex stimulation

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Saeid Metwaly Elsawy
• United Kingdom
  • London, United Kingdom, N15 4DW
    • Saeid Elsawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: tDCS sham motor cortex; 25 participants will have sham stimulation for 20 minutes using transcranial direct current stimulation device.	Device: tDCS sham motor cortex; 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.
ACTIVE_COMPARATOR: Active motor cortex stimulation; 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; 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
ACTIVE_COMPARATOR: 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.	Device: active prefrontal cortex stimulation; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Saeid M Elsawy, MBBch, Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (ACTUAL): September 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: post tDCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No