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Clinical Trials/NCT03278184
NCT03278184
Completed
Not Applicable

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

Assiut University2 sites in 2 countries75 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
Assiut University
Enrollment
75
Locations
2
Primary Endpoint
the total consumption of morphine administered by patients during the first two days postoperative
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
November 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Saeid Metwaly Abouelyazid Elsawy

Assistant lecturer

Assiut University

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
  • 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

Outcomes

Primary Outcomes

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

  • Pain severity assessment using visual analogue scale (VAS score from 0-10)(30 minutes after every sessions and at the third day)
  • HADS score(before surgery and at the third day)

Study Sites (2)

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