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Completed

NCT Number: NCT03278184

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saeid Metwaly Elsawy, Asyut, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS sham motor cortex

Device

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

Device

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

Device

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

Primary outcomes

  1. the total consumption of morphine administered by patients during the first two days postoperative

    Time frame: 48 hours postoperative

    the investigator will calculate the amount of morphine used during the first two days postoperative.

Secondary outcomes

  1. Pain severity assessment using visual analogue scale (VAS score from 0-10)

    Time frame: 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

  2. HADS score

    Time frame: before surgery and at the third day

    hospital anexiety and depression score

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2017
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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