Clinical trial NCT03278184: Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery
Official title: The Role of Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery, Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the total consumption of morphine administered by patients during the first two days postoperative
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: Pain severity assessment using visual analogue scale (VAS score from 0-10)
timeFrame: 30 minutes after every sessions and at the third day
measure: HADS score
timeFrame: before surgery and at the third day
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Saeid Metwaly Elsawy
city: London
country: United Kingdom
facility: Saeid Elsawy
Study officials:
affiliation: Assiut University
name: Saeid M Elsawy, MBBch
role: PRINCIPAL_INVESTIGATOR
References: