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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278184
• Other study ID #: post tDCS
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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 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
• 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

Locations

Country	Name	City	State
Egypt	Saeid Metwaly Elsawy	Assiut
United Kingdom	Saeid Elsawy	London

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Countries where clinical trial is conducted

Egypt,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	HADS score	hospital anexiety and depression score	before surgery and at the third day